{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 65
    }
  },
  "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": "Calculi Strainer / Kidney Stone Collector (2 Pack)",
      "public_device_record_key": "ff777fb5-9371-43e0-8670-253a42a67370",
      "has_serial_number": "false",
      "public_version_date": "2021-10-25",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "true",
      "public_version_number": "1",
      "labeler_duns_number": "079767953",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00810077211649",
          "type": "Unit of Use",
          "issuing_agency": "GS1"
        },
        {
          "id": "00810077211656",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "false",
      "version_or_model_number": "VKKSC02",
      "has_manufacturing_date": "false",
      "brand_name": "Avaline Medical NJ LLC",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "FNP",
          "name": "URINAL",
          "openfda": {
            "device_name": "Urinal",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.6730",
            "device_class": "1"
          }
        }
      ],
      "device_count_in_base_package": "2",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "false",
      "customer_contacts": [
        {
          "phone": "+1(732)813-7799",
          "ext": "204",
          "email": "jstein@avalinemedical.com"
        }
      ],
      "catalog_number": "VKKSC02",
      "company_name": "Avaline Medical NJ Limited Liability Company",
      "public_version_status": "New",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "14302",
          "name": "Urine strainer",
          "definition": "A device designed to collect stones (calculi) from urine during normal micturition (urination). It is typically designed as a sieve-like container with handles for holding and emptying, and is typically mounted into a funnel/holder system that may be attached to a dedicated treatment table or chair. The collected stones are typically sent to the clinical laboratory for examination and composition determination to facilitate patient diagnosis and/or therapy. This is a reusable device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2021-10-15"
    }
  ]
}