properties:
  brand_name:
    description: "The Proprietary/Trade/Brand name of the medical device as used in device labeling or in the catalog. This information may 1) be on a label attached to a durable device, 2) be on a package of a disposable device, or 3) appear in labeling materials of an implantable device. The brand name is the name that is typically registered with USPTO and have the ® and/or TM symbol."
    format:
    is_exact: true
    possible_values:
    type: string
  catalog_number:
    description: "The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product."
    format:
    is_exact: true
    possible_values:
    type: string
  commercial_distribution_end_date:
    description: "Indicates the date the device is no longer held or offered for sale. See 21 CFR 807.3(b) for exceptions. The device may or may not still be available for purchase in the marketplace."
    format: date
    is_exact: false
    possible_values:
    type: date
  commercial_distribution_status:
    description: "Indicates whether the device is in commercial distribution as defined under 21 CFR 807.3(b)."
    format:
    is_exact: true
    possible_values:
      type: one_of
      value:
       'In Commercial Distribution': "In Commercial Distribution"
       'Not in Commercial Distribution': "Not in Commercial Distribution"
    type: string
  company_name:
    description: "Company name associated with the labeler DUNS Number entered in the DI Record."
    format:
    is_exact: true
    possible_values:
    type: string
  customer_contacts:
    items:
      properties:
        email:
          description: "Email for the Customer contact; to be used by patients and consumers for device-related questions."
          format:
          is_exact: false
          possible_values:
          type: string
        phone:
          description: "Phone number for the customer contact; to be used by patients and consumers for device-related questions."
          format:
          is_exact: false
          possible_values:
          type: string
      type: object
    type: array
  device_count_in_base_package:
    description: "Number of medical devices in the base package."
    format:
    is_exact: false
    possible_values:
    type: integer
  device_description:
    description: "Additional relevant information about the device that is not already captured as a distinct GUDID data attribute."
    format:
    is_exact: false
    possible_values:
    type: string
  device_sizes:
    items:
      properties:
        text:
          description: "Additional undefined device size not represented in the GUDID Size Type LOV."
          format:
          is_exact: false
          possible_values:
          type: string
        type:
          description: "Dimension type for the clinically relevant measurement of the medical device."
          format:
          is_exact: true
          possible_values:
            type: one_of
            value:
             'Circumference': "Circumference"
             'Depth; Device Size Text, specify;': "Depth; Device Size Text, specify;"
             'Catheter Gauge': "Catheter Gauge"
             'Outer Diameter': "Outer Diameter"
             'Height': "Height"
             'Length': "Length"
             'Lumen/Inner Diameter': "Lumen/Inner Diameter"
             'Needle Gauge': "Needle Gauge"
             'Total Volume': "Total Volume"
             'Width': "Width"
             'Weight': "Weight"
             'Pressure': "Pressure"
             'Pore Size': "Pore Size"
             'Area/Surface Area': "Area/Surface Area"
             'Angle': "Angle"
          type: string
        unit:
          description: "The unit of measure associated with each clinically relevant size."
          format:
          is_exact: false
          possible_values:
            type: one_of
            value:
             'Centiliter': "Centiliter"
             'Centimeter': "Centimeter"
             'Cubic Inch': "Cubic Inch"
             'Cup': "Cup"
             'Deciliter': "Deciliter"
             'Decimeter': "Decimeter"
             'degree': "degree"
             'Feet': "Feet"
             'Femtoliter': "Femtoliter"
             'Femtometer': "Femtometer"
             'Fluid Ounce': "Fluid Ounce"
             'French': "French"
             'Gallon': "Gallon"
             'Gauge': "Gauge"
             'Gram': "Gram"
             'Hertz': "Hertz"
             'Inch': "Inch"
             'Kilogram': "Kilogram"
             'Kiloliter': "Kiloliter"
             'Kilometer': "Kilometer"
             'KiloPascal': "KiloPascal"
             'Liter': "Liter"
             'Meter': "Meter"
             'Microgram': "Microgram"
             'Microliter': "Microliter"
             'Micrometer': "Micrometer"
             'millibar': "millibar"
             'Milligram': "Milligram"
             'Milliliter': "Milliliter"
             'Millimeter': "Millimeter"
             'Nanoliter': "Nanoliter"
             'Nanometer': "Nanometer"
             'Picoliter': "Picoliter"
             'Picometer': "Picometer"
             'Pint': "Pint"
             'Pound': "Pound"
             'Pound per Square Inch': "Pound per Square Inch"
             'Quart': "Quart"
             'Square centimeter': "Square centimeter"
             'Square foot': "Square foot"
             'Square inch': "Square inch"
             'Square meter': "Square meter"
             'Ton': "Ton"
             'Yard': "Yard"
          type: string
        value:
          description: "Numeric value for the clinically relevant size measurement of the medical device."
          format: double
          is_exact: false
          possible_values:
          type: string
      type: object
    type: array
  gmdn_terms:
    items:
      properties:
        code:
          description: "GMDN Preferred Term Code of the common device type associated with the FDA PT Code."
          format:
          is_exact: false
          possible_values:
          type: string
        definition:
          description: "Definition of the common device type associated with the GMDN Preferred Term Code/FDA PT Code."
          format:
          is_exact: false
          possible_values:
          type: string
        name:
          description: "Name of the common device type associated with the GMDN Preferred Term Code/FDA PT Code."
          format:
          is_exact: true
          possible_values:
          type: string
        implantable:
          description: "GMDN Implantable flag."
          format:
          is_exact: false
          possible_values:
            type: one_of
            value:
              'true': "true"
              'false': "false"
          type: boolean
        code_status:
          description: "GMDN Term Status, Active or Obsolete."
          format:
          is_exact: false
          possible_values:
            type: one_of
            value:
              'Active': "Active"
              'Obsolete': "Obsolete"
          type: boolean
      type: object
    type: array
  has_donation_id_number:
    description: "The Donation Identification Number is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation.This number/code is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  has_expiration_date:
    description: "The date by which the label of a device states the device must or should be used. This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  has_lot_or_batch_number:
    description: "The number assigned to one or more device(s) that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  has_manufacturing_date:
    description: "The date on which a device is manufactured.This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  has_serial_number:
    description: "The number that allows for the identification of a device, indicating its position within a series. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  identifiers:
    items:
      properties:
        id:
          description: "A unique numeric or alphanumeric code specific to a device version or model."
          format:
          is_exact: false
          possible_values:
          type: string
        issuing_agency:
          description: "Organization accredited by FDA to operate a system for the issuance of UDIs"
          format:
          is_exact: true
          possible_values:
            type: one_of
            value:
             'GS1': "GS1"
             'ICCBBA': "ICCBBA"
             'HIBCC': "HIBCC"
             'NDC/NHRIC': "NDC/NHRIC"
          type: string
        package_discontinue_date:
          description: "Indicates the date this particular package configuration is discontinued by the Labeler or removed from the marketplace."
          format: date
          is_exact: false
          possible_values:
          type: date
        package_status:
          description: "Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b)."
          format:
          is_exact: true
          possible_values:
            type: one_of
            value:
             'In Commercial Distribution': "In Commercial Distribution"
             'Not in Commercial Distribution': "Not in Commercial Distribution"
          type: string
        package_type:
          description: "The type of packaging used for the device."
          is_exact: false
          possible_values:
          type: string
        quantity_per_package:
          description: "The number of packages with the same Primary DI or Package DI within a given packaging configuration."
          format:
          is_exact: false
          possible_values:
          type: integer
        type:
          description: "Indicates whether the identifier is the Primary, Secondary, Direct Marking, Unit of Use, Package, or Previous DI"
          format:
          is_exact: false
          possible_values:
            type: one_of
            value:
              'Primary': "Primary DI. An identifier that is the main (primary) lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use.  The primary DI number will be located on the base package, which is the lowest package level of a medical device containing a full UDI.  For medical devices without packaging, the primary DI number and full UDI may be on the device itself."
              'Secondary': "Secondary DI. An identifier that is an alternate (secondary) lookup for a medical device that is issued from a different issuing agency than the primary DI. Under 21 CFR 830.40(a), only one device identifier from any particular system for the issuance of UDIs may be used to identify a particular version or model of a device."
              'Direct Marking': "Direct Marking DI. An identifier that is marked directly on the medical device and is different than the Primary DI Number; only applicable to devices subject to Direct Marking requirements under 21 CFR 801.45."
              'Unit of Use': "Unit of Use DI. An identifier assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to associate the use of a device to/on a patient."
              'Package': "Package DI. A device identifier for the package configuration that contains multiple units of the base package (does not include shipping containers)."
              'Previous DI': "Previous DI"
          type: string
        unit_of_use_id:
          description: "An identifier assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to associate the use of a device to/on a patient. Unit of Use DI is an identifier used by hospital staff and Materials Management to account for a single device when the UDI is labeled on a higher level of packaging. The Unit of Use DI does not appear on the label. Data type and field length are determined by the individual Issuing Agency structure."
          format:
          is_exact: false
          possible_values:
          type: string
      type: object
    type: array
  is_combination_product:
    description: "Indicates that the product is comprised of two or more regulated products that are physically, chemically, or otherwise combined or mixed and produced as a single entity; packaged together as a single package; or packaged separately for the intended use together as defined under 21 CFR 3.2(e). At least one of the products in the combination product must be a device in this case."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  is_direct_marking_exempt:
    description: "The device is exempt from Direct Marking requirements under 21 CFR 801.45."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  is_hct_p:
    description: "Indicates that the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  is_kit:
    description: "Indicates that the device is a convenience, combination, in vitro  diagnostic (IVD), or medical procedure kit. Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and are being distributed as a medical device."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  is_labeled_as_no_nrl:
    description: "Indicates that natural rubber latex was not used as materials in the manufacture of the medical product and container and the device labeling contains this information.  Only applicable to devices not subject to the requirements under 21 CFR 801.437.  Not all medical products that are NOT made with natural rubber latex will be marked."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  is_labeled_as_nrl:
    description: "Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. The value `true` indicates that the device label or packaging contains one of the following statements: (1) 'Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions', (2) 'This Product Contains Dry Natural Rubber', (3) 'Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions' or (4) 'The Packaging of This Product Contains Dry Natural Rubber'."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  is_otc:
    description: "Indicates that the device does not require a prescription to use and can be purchased over the counter."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  is_pm_exempt:
    description: "Indicates whether the device is exempt from premarket notification requirements."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  is_rx:
    description: "Indicates whether the device requires a prescription."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  is_single_use:
    description: "Indicates that the device is intended for one use or on a single patient during a single procedure."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'true': 'true'
       'false': 'false'
    type: boolean
  labeler_duns_number:
      description: "The DUNS Number is a unique nine-digit identifier for businesses. It is used to establish a D&B® business credit file, which is often referenced by lenders and potential business partners to help predict the reliability and/or financial stability of the company in question. [The Dun & Bradstreet disclaimer text to go here]"
      format:
      is_exact: false
      possible_values:
      type: string
  mri_safety:
    description: "Indicates the MRI Safety Information, if any, that is present in the device labeling. Please see the ASTM F2503-13 standard for more information."
    format:
    is_exact: true
    possible_values:
      type: one_of
      value:
       'MR Safe': "MR Safe"
       'MR Unsafe': "MR Unsafe"
       'MR Conditional': "MR Conditional"
       'Labeling does not contain MRI Safety Information': "Labeling does not contain MRI Safety Information"
    type: string
  premarket_submissions:
    items:
      properties:
        submission_number:
          description: "Number associated with the regulatory decision regarding the applicant’s legal right to market a medical device for the following submission types: 510(k), PMA, PDP, HDE, BLA, and NDA."
          format:
          is_exact: false
          possible_values:
          type: string
        supplement_number:
          description: "Number assigned by FDA to a supplemental application for approval of a change in a medical device with an approved PMA."
          format:
          is_exact: false
          possible_values:
          type: string
        submission_type:
          description: "Indicates the premarket submission type."
          format:
          is_exact: false
          possible_values:
            type: one_of
            value:
             '510(k)': "510(k)"
             'PMA': "PMA"
             'PDP': "PDP"
             'HDE': "HDE"
             'BLA': "BLA"
             'NDA': "NDA"
          type: string
      type: object
    type: array
  product_codes:
    items:
      properties:
        code:
          description: "A three-letter identifier assigned to a device category"
          format:
          is_exact: true
          possible_values:
          type: string
        name:
          description: "Name associated with the three-letter Product Code"
          format:
          is_exact: false
          possible_values:
          type: string
        openfda:
          type: object
          properties:
            device_class:
              description: "A risk based classification system for all medical devices ((Federal Food, Drug, and Cosmetic Act, section 513)."
              format:
              is_exact: false
              possible_values:
                type: one_of
                value:
                 '1': "Class I (low to moderate risk): general controls"
                 '2': "Class II (moderate to high risk): general controls and special controls"
                 '3': "Class III (high risk): general controls and Premarket Approval (PMA)"
                 'U': "Unclassified"
                 'N': "Not classified"
                 'F': "HDE"
              type: string
            device_name:
              description: "This is the proprietary name, or trade name, of the cleared device."
              format:
              is_exact: true
              possible_values:
              type: string
            medical_specialty_description:
              description: "Regulation Medical Specialty is assigned based on the regulation (e.g. 21 CFR Part 888 is Orthopedic Devices) which is why Class 3 devices lack the 'Regulation Medical Specialty' field."
              format:
              is_exact: true
              possible_values:
              type: string
            regulation_number:
              description: "The classification regulation in the Code of Federal Regulations (CFR) under which the device is identified, described, and formally classified (Code of Federal regulations Title 21, 862.00 through 892.00). The classification regulation covers various aspects of design, clinical evaluation, manufacturing, packaging, labeling, and postmarket surveillance of the specific medical device."
              format:
              is_exact: true
              possible_values:
              type: string
      type: object
    type: array
  publish_date:
    description: "Indicates the date the DI Record gets published and is available via Public Search."
    format: date
    is_exact: false
    possible_values:
    type: date
  public_version_date:
    description: "Auto assigned the day file is generated with Time Stamp; All existing records will have first date assigned the day download file is generated with this data element."
    format: date
    is_exact: false
    possible_values:
    type: date
  public_version_number:
    description: "Auto assigned version number, assigned just before file generation; All existing records will have version 1 assigned."
    format:
    is_exact: false
    possible_values:
    type: string
  public_version_status:
    description: "Definition forthcoming."
    format:
    is_exact: false
    possible_values:
    type: string
  record_key:
    description: "Current enhancements will allow the Primary DI to change after the DI record has been released to the public. To ensure records can be linked and managed, a record key will be provided; Unique alphanumeric value, auto generated."
    format:
    is_exact: false
    possible_values:
    type: string
  record_status:
    description: "Indicates the status of the DI Record."
    format:
    is_exact: false
    possible_values:
      type: one_of
      value:
       'Published': "Published"
       'Unpublished': "Unpublished"
       'Deactivated': "Deactivated"
    type: string
  sterilization:
    type: object
    properties:
      is_sterile:
        description: "Indicates the medical device is free from viable microorganisms. See ISO/TS 11139."
        format:
        is_exact: false
        possible_values:
          type: one_of
          value:
           'true': 'true'
           'false': 'false'
        type: boolean
      is_sterilization_prior_use:
        description: "Indicates that the device requires sterilization prior to use."
        format:
        is_exact: false
        possible_values:
          type: one_of
          value:
           'true': 'true'
           'false': 'false'
        type: boolean
      sterilization_methods:
        description: " Indicates the method(s) of sterilization that can be used for this device."
        format:
        is_exact: false
        possible_values:
          type: one_of
          value:
           'Chlorine Dioxide': "Chlorine Dioxide"
           'Dry Heat Sterilization': "Dry Heat Sterilization"
           'Ethylene Oxide': "Ethylene Oxide"
           'High Intensity Light or Pulse Light': "High Intensity Light or Pulse Light"
           'High-level Disinfectant': "High-level Disinfectant"
           'Hydrogen Peroxide': "Hydrogen Peroxide"
           'Liquid Chemical': "Liquid Chemical"
           'Microwave Radiation': "Microwave Radiation"
           'Moist Heat or Steam Sterilization': "Moist Heat or Steam Sterilization"
           'Nitrogen Dioxide': "Nitrogen Dioxide"
           'Ozone': "Ozone"
           'Peracetic Acid': "Peracetic Acid"
           'Radiation Sterilization': "Radiation Sterilization"
           'Sound Waves': "Sound Waves"
           'Supercritical Carbon Dioxide': "Supercritical Carbon Dioxide"
           'Ultraviolet Light': "Ultraviolet Light"
        type: string
  storage:
    items:
      properties:
        high:
          properties:
            unit:
              description: "The high value unit of measure associated with the storage and handling conditions."
              format:
              is_exact: false
              possible_values:
                type: one_of
                value:
                 'Degrees Celsius': "Degrees Celsius"
                 'Degrees Fahrenheit': "Degrees Fahrenheit"
                 'Degrees Kelvin': "Degrees Kelvin"
                 'Kilo Pascal': "Kilo Pascal"
                 'Percent (%) Relative Humidity, Millibar': "Percent (%) Relative Humidity,Millibar"
              type: string
            value:
              description: "Indicates the high value for storage and handling requirements."
              format:
              is_exact: false
              possible_values:
              type: string
          type: object
        low:
          properties:
            unit:
              description: "The low value unit of measure associated with the storage and handling conditions."
              format:
              is_exact: false
              possible_values:
              type: string
            value:
              description: "Indicates the low value for storage and handling requirements."
              format:
              is_exact: false
              possible_values:
                type: one_of
                value:
                 'Degrees Celsius': "Degrees Celsius"
                 'Degrees Fahrenheit': "Degrees Fahrenheit"
                 'Degrees Kelvin': "Degrees Kelvin"
                 'Kilo Pascal': "Kilo Pascal"
                 'Percent (%) Relative Humidity, Millibar': "Percent (%) Relative Humidity,Millibar"
              type: string
          type: object
        special_conditions:
          description: "Indicates any special storage requirements for the device."
          format:
          is_exact: true
          possible_values:
          type: string
        type:
          description: "Indicates storage and handling requirements for the device including temperature, humidity, and atmospheric pressure."
          format:
          is_exact: true
          possible_values:
            type: one_of
            value:
             'Handling Environment Atmospheric Pressure': "Handling Environment Atmospheric Pressure"
             'Handling Environment Humidity': "Handling Environment Humidity"
             'Handling Environment Temperature': "Handling Environment Temperature"
             'Special Storage Conditions': "Special Storage Conditions"
             'Storage Environment Atmospheric Pressure': "Storage Environment Atmospheric Pressure"
             'Storage Environment Humidity': "Storage Environment Humidity"
             'Storage Environment Temperature': "Storage Environment Temperature"
          type: string
      type: object
    type: array
  version_or_model_number:
    description: "The version or model found on the device label or accompanying packaging used to identify a category or design of a device. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler."
    format:
    is_exact: true
    possible_values:
    type: string
type: object