{
  "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": "1 ea - Valved Hydrogel Dressing / 1 ea - Gauze Pad\nINTENDED USE:  FOR THE INITIAL MANAGEMENT OF PENETRATING CHEST INJURIES",
      "public_device_record_key": "91e907df-b80e-49a7-8803-3d55dc50cd2b",
      "has_serial_number": "false",
      "public_version_date": "2025-10-28",
      "commercial_distribution_end_date": "2030-09-19",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "2",
      "labeler_duns_number": "118492643",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "M689BCS01040",
          "type": "Primary",
          "issuing_agency": "HIBCC"
        }
      ],
      "is_single_use": "true",
      "is_otc": "true",
      "version_or_model_number": "04",
      "has_manufacturing_date": "false",
      "brand_name": "Bolin Chest Seal",
      "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": "855-428-6074",
          "email": "fulfillment@combatmedical.com"
        }
      ],
      "catalog_number": "BCS01",
      "company_name": "Safeguard US Operating, LLC",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "46424",
          "name": "Pneumothorax dressing",
          "definition": "A sterile covering applied to a chest wound that has penetrated the pleura (serous membrane covering the lungs and lining the pleural cavity) in order to temporarily treat and prevent pneumothorax (collapsed lung). The device may be self-adhesive and have a one-way valve that enables internal pressure release while preventing air entry. It is typically used by first responders [emergency medical services (EMS)] in the management of penetrating chest trauma (e.g., bullet or stab wounds). This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2023-10-05"
    }
  ]
}