{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Leukotrap RC System CP2D/AS-3 triple blood bag unit with in-line RC2D filter and sampling system DEXTROSE, UNSPECIFIED FORM ANHYDROUS DEXTROSE CITRIC ACID MONOHYDRATE WATER SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SODIUM CITRATE"
      ],
      "intended_use_of_the_device": [
        "For collection of 500ml of whole blood and preapration of red blood cells and plasma or red blood cells, plasma and platelets with pre-storage leukocyte reduction of red blood cells."
      ],
      "description": [
        "Leukotrap RC System CP2D/AS-3 - Triple blood bag unit with In-Line RC2D filter and sampling system"
      ],
      "how_supplied": [
        "Sterile, Non-pyrogenic fluid pathway. Sterilized by Steam"
      ],
      "storage_and_handling": [
        "Store at room temperature. Unused bags in opened pouches may be kept 30 days by folding and securing open end of pouch to prevent possible loss of moisture."
      ],
      "package_label_principal_display_panel": [
        "Bag label 1 Bag label 2 Bag label Pouch label Case Label IFU IFU IFU"
      ],
      "set_id": "4c0dec79-1648-1cfd-e063-6394a90a88cc",
      "id": "532f6802-a18b-067c-e063-6294a90ac3a7",
      "effective_time": "20260601",
      "version": "2",
      "openfda": {
        "application_number": [
          "BN820915"
        ],
        "brand_name": [
          "Leukotrap RC System"
        ],
        "generic_name": [
          "CP2D/AS-3 TRIPLE BLOOD BAG UNIT WITH IN-LINE RC2D FILTER AND SAMPLING SYSTEM"
        ],
        "manufacturer_name": [
          "GVS TM INC"
        ],
        "product_ndc": [
          "87069-129"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DEXTROSE, UNSPECIFIED FORM"
        ],
        "spl_id": [
          "532f6802-a18b-067c-e063-6294a90ac3a7"
        ],
        "spl_set_id": [
          "4c0dec79-1648-1cfd-e063-6394a90a88cc"
        ],
        "package_ndc": [
          "87069-129-63"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "IY9XDZ35W2"
        ]
      }
    }
  ]
}