{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "UK Halo Vent Single Pack IFAk, 1 Halo Vent 5.5\" x 7.5\" with CE Mark. This device is a non-resorbable and non-sterile, occlusive wound dressing, intended to cover a wound and to provide a mechanical barrier. The vented seal allows air, gases, and fluids to escape from inside the chest through the device.  Each package contains quantity: 1 Halo Vent.",
      "public_device_record_key": "09a069b9-01d7-4e10-bc0e-3b3b8f17d605",
      "has_serial_number": "false",
      "storage": [
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "140"
          },
          "low": {
            "unit": "Degrees Fahrenheit",
            "value": "-30"
          }
        },
        {
          "type": "Handling Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "140"
          },
          "low": {
            "unit": "Degrees Fahrenheit",
            "value": "-30"
          }
        }
      ],
      "public_version_date": "2026-03-02",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "101571834",
      "is_labeled_as_no_nrl": "true",
      "identifiers": [
        {
          "id": "00850010608235",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00850010608228",
          "quantity_per_package": "200",
          "package_status": "In Commercial Distribution",
          "package_type": "Case"
        },
        {
          "id": "00850010608228",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "true",
      "version_or_model_number": "UK 1216-10008",
      "has_manufacturing_date": "true",
      "brand_name": "Halo",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "NAD",
          "name": "Dressing, Wound, Occlusive",
          "openfda": {
            "device_name": "Dressing, Wound, Occlusive",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4020",
            "device_class": "1"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "800.828.4681",
          "email": "info@medicaldevicesinc.com"
        }
      ],
      "catalog_number": "UK 1216-10008",
      "company_name": "Medical Devices, Inc.",
      "public_version_status": "New",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "47764",
          "name": "Wound hydrogel dressing, non-antimicrobial",
          "definition": "A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2026-02-20"
    }
  ]
}