{
  "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": 4
    }
  },
  "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": "TUBE K2EDTA PLH 13X100 6.0 PLBL LAV",
      "public_device_record_key": "bb6ae0ba-a0ff-4e0f-aec1-c7c13ee51601",
      "has_serial_number": "false",
      "storage": [
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Celsius",
            "value": "25"
          },
          "low": {
            "unit": "Degrees Celsius",
            "value": "4"
          }
        }
      ],
      "public_version_date": "2024-05-02",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "7",
      "labeler_duns_number": "001292192",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "30382903678632",
          "type": "Primary",
          "issuing_agency": "GS1"
        },
        {
          "id": "00382903678631",
          "type": "Unit of Use",
          "issuing_agency": "GS1"
        },
        {
          "id": "50382903678636",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "30382903678632",
          "quantity_per_package": "10",
          "package_status": "In Commercial Distribution",
          "package_type": "Case"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "367863",
      "has_manufacturing_date": "true",
      "brand_name": "BD Vacutainer® K2 EDTA (K2E) 10.8mg Blood Collection Tubes",
      "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": "GIM",
          "name": "Tubes, vacuum sample, with anticoagulant",
          "openfda": {
            "device_name": "Tubes, Vacuum Sample, With Anticoagulant",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1675",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "BK230980",
          "supplement_number": "000"
        },
        {
          "submission_number": "K213670",
          "supplement_number": "000"
        },
        {
          "submission_number": "K231373",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "100",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "catalog_number": "367863",
      "company_name": "BECTON, DICKINSON AND COMPANY",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "47592",
          "name": "Evacuated blood collection tube IVD, anticoagulant",
          "definition": "A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and an anticoagulant [e.g., sodium heparin, sodium citrate, potassium oxalate, ethylenediaminetetraacetic acid (EDTA)]. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood lead, toxicology, nutritional-chemistry, and other plasma chemistry determinations). This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-07-28"
    }
  ]
}