{
  "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": "BLUE Food Service Metal Detectable Adhesive Bandage - 3\" x 1\"",
      "public_device_record_key": "ae3829f4-dbb7-4b4d-bb32-6ef47a0a6b7d",
      "has_serial_number": "false",
      "public_version_date": "2025-09-11",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "079767953",
      "is_labeled_as_no_nrl": "true",
      "identifiers": [
        {
          "id": "00810124532475",
          "type": "Unit of Use",
          "issuing_agency": "GS1"
        },
        {
          "id": "00810124532451",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "true",
      "version_or_model_number": "blu ban 1X3 1200",
      "has_manufacturing_date": "false",
      "brand_name": "Avaline Medical NJ LLC",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "KGX",
          "name": "Tape and bandage, adhesive",
          "openfda": {
            "device_name": "Tape And Bandage, Adhesive",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.5240",
            "device_class": "1"
          }
        }
      ],
      "device_count_in_base_package": "1200",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "false",
      "customer_contacts": [
        {
          "phone": "+1(732)813-7799",
          "ext": "204",
          "email": "jstein@avalinemedical.com"
        }
      ],
      "company_name": "Avaline Medical NJ Limited Liability Company",
      "public_version_status": "New",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "34864",
          "name": "Adhesive bandage",
          "definition": "A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2025-09-03"
    }
  ]
}