{
  "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": "2026-07-13",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "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": "true",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Unistik ShieldLock 25G Safety Winged Set w/ Luer and Holder 12\" tubing",
      "public_device_record_key": "ec265e53-6423-4836-893f-a9f7e2f16fbe",
      "has_serial_number": "false",
      "public_version_date": "2023-10-16",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "803401454",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00384707522035",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00384707522011",
          "quantity_per_package": "1000",
          "package_status": "In Commercial Distribution",
          "package_type": "Case"
        },
        {
          "id": "00384707522011",
          "type": "Primary",
          "issuing_agency": "GS1"
        },
        {
          "id": "00384707522004",
          "type": "Unit of Use",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "WS 7522",
      "has_manufacturing_date": "true",
      "brand_name": "Unistik ShieldLock",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "JKA",
          "name": "Tubes, Vials, Systems, Serum Separators, Blood Collection",
          "openfda": {
            "device_name": "Tubes, Vials, Systems, Serum Separators, Blood Collection",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1675",
            "device_class": "2"
          }
        },
        {
          "code": "FMI",
          "name": "Needle, Hypodermic, Single Lumen",
          "openfda": {
            "device_name": "Needle, Hypodermic, Single Lumen",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.5570",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K223854",
          "supplement_number": "000"
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      ],
      "device_count_in_base_package": "50",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "company_name": "OWEN MUMFORD USA INCORPORATED",
      "public_version_status": "New",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "58497",
          "name": "Blood collection set, invasive",
          "definition": "A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2023-10-06"
    }
  ]
}