{
  "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": "ASSUREMASK  - PROCEDURE EARLOOP FACE MASK - LEVEL 3 - BLUE",
      "public_device_record_key": "d6adaccc-f292-4a26-ab12-b0134867c4e4",
      "has_serial_number": "false",
      "storage": [
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "104"
          }
        },
        {
          "type": "Special Storage Condition, Specify",
          "special_conditions": "Cool dry place"
        },
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Celsius",
            "value": "40"
          }
        }
      ],
      "public_version_date": "2026-03-25",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "256880576",
      "is_labeled_as_no_nrl": "true",
      "identifiers": [
        {
          "id": "20686864061933",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "10686864061936",
          "quantity_per_package": "50",
          "package_status": "In Commercial Distribution",
          "package_type": "case"
        },
        {
          "id": "10686864061936",
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        {
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          "type": "Unit of Use",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "true",
      "version_or_model_number": "205915-B",
      "has_manufacturing_date": "false",
      "brand_name": "MEDICOM ASSUREMASK VALIANT",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "FXX",
          "name": "Mask, surgical",
          "openfda": {
            "device_name": "Mask, Surgical",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4040",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "50",
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      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+1(514)636-6262",
          "email": "mdasilva@medicom.ca"
        }
      ],
      "catalog_number": "205915-B",
      "company_name": "AMD Medicom Inc",
      "public_version_status": "New",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "66199",
          "name": "Surgical/medical face mask, non-antimicrobial, single-use",
          "definition": "A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2026-03-17"
    }
  ]
}