{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "CP2D CP2D CITRIC ACID MONOHYDRATE SODIUM CITRATE MONOBASIC POTASSIUM PHOSPHATE DEXTROSE, UNSPECIFIED FORM ANHYDROUS DEXTROSE"
      ],
      "intended_use_of_the_device": [
        "Intended for use only with automated red cell apheresis devices to collect red blood cells and plasma (FFP and PF24). Intended use"
      ],
      "storage_and_handling": [
        "Storage and handling section Store at room temperature (25 °C/77 °F). Avoid excessive heat. Protect from freezing. Storage and handling"
      ],
      "warnings_and_cautions": [
        "Warnings and precautions Warnings Not for direct intravenous infusion. Single-use container – discard unused portion. (do not reuse) Do not use unless the solution is clear and no leaks are detected. Precautions Use only with automated red-cell apheresis devices and follow the Operator’s Manual. Refer to the package insert for complete instructions. Storage/handling: Store at 25 °C/77 °F, avoid excessive heat, protect from freezing. Pouch is a moisture barrier; handle to maintain package integrity. Warnings and precautions"
      ],
      "description": [
        "Description section ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D), 250 mL 0455A-00 Description"
      ],
      "statement_of_identity": [
        "Statement of identity ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D), 250 mL 0455A-00 Statement of identity"
      ],
      "package_label_principal_display_panel": [
        "Package label Manufacturer information: GVS TM Inc. 1630 W Industrial Park St Covina, CA 91722, USA ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION (CP2D), 250 mL Intended for use only with automated red cell apheresis devices to collect red blood cells and plasma (FFP and PF24). See the appropriate Operator’s Manual for additional information and complete usage instructions. Each 100 mL contains: Citric Acid (Monohydrate), USP 0.327 g Sodium Citrate (Dihydrate), USP 2.630 g Monobasic Sodium Phosphate (Monohydrate), USP 0.222 g Dextrose (Anhydrous), USP 4.640 g CAUTION: Refer to package insert. Not for direct intravenous infusion. The pouch is a moisture barrier. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx Only. Store at room temperature (25 °C/77 °F). Avoid excessive heat. Protect from freezing. REF: 0455A-00 lot and expiry date 126616-00 REV.0 - template number Package label"
      ],
      "set_id": "3fa2e438-2ff0-a2df-e063-6394a90ac7b5",
      "id": "42ece7e1-1da0-7e5a-e063-6294a90ac803",
      "effective_time": "20251106",
      "version": "2",
      "openfda": {
        "application_number": [
          "BN820915"
        ],
        "brand_name": [
          "CP2D"
        ],
        "generic_name": [
          "CP2D"
        ],
        "manufacturer_name": [
          "GVS TM INC"
        ],
        "product_ndc": [
          "87069-455"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DEXTROSE, UNSPECIFIED FORM"
        ],
        "spl_id": [
          "42ece7e1-1da0-7e5a-e063-6294a90ac803"
        ],
        "spl_set_id": [
          "3fa2e438-2ff0-a2df-e063-6394a90ac7b5"
        ],
        "package_ndc": [
          "87069-455-42"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "IY9XDZ35W2"
        ]
      }
    }
  ]
}