{
  "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": "SafeWash™ Saline is a sterile first-aid, multi-use jet lavage for wound dressing irrigation and wound cleansing. SafeWash™ Saline wound wash is intended for:  moistening and lubricating absorbent wound dressings; cleansing wounds, scrapes and minor burns; flushing and cleansing wounds of exudate, loose necrotic tissue, and foreign material such as dirt and debris.  Contains 0.9% Sodium Chloride Solution.",
      "public_device_record_key": "972fd3bf-a11c-486e-9c55-5601dd4c2e0e",
      "has_serial_number": "false",
      "public_version_date": "2026-02-23",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "3",
      "labeler_duns_number": "118753405",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00714196245076",
          "type": "Primary",
          "issuing_agency": "GS1"
        },
        {
          "id": "10714196245073",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00714196245076",
          "quantity_per_package": "12",
          "package_status": "In Commercial Distribution",
          "package_type": "Case"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "00245",
      "has_manufacturing_date": "false",
      "brand_name": "SafeWash Saline",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "FQH",
          "name": "Lavage, Jet",
          "openfda": {
            "device_name": "Lavage, Jet",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.5475",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "true",
      "company_name": "Sion Brands LLC",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "37298",
          "name": "Wound irrigation sterile saline",
          "definition": "A sterile solution of sodium chloride (NaCl), sometimes with additional compounds, intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and is typically provided in an appropriate container. After application, this device cannot be reused.",
          "implantable": "false",
          "code_status": "Obsolete"
        }
      ],
      "publish_date": "2016-09-20"
    }
  ]
}