{
  "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,
      "total": 2
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "AS-3 AS-3 SODIUM CITRATE, UNSPECIFIED FORM SODIUM CHLORIDE CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE ADENINE ADENINE DEXTROSE, UNSPECIFIED FORM ANHYDROUS DEXTROSE AS-3 AS-3 SODIUM CITRATE, UNSPECIFIED FORM ADENINE ADENINE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE CITRIC ACID MONOHYDRATE SODIUM CHLORIDE DEXTROSE, UNSPECIFIED FORM ANHYDROUS DEXTROSE"
      ],
      "intended_use_of_the_device": [
        "Intended use of the device Intended for use only with automated red cell washing devices and automated red cell apheresis devices. Intended use",
        "I Intended for use only with automated red cell apheresis devices. Intended use"
      ],
      "storage_and_handling": [
        "Storage and handling Store at room temperature (25 °C/77 °F). Avoid excessive heat. Protect from freezing Storage and handling",
        "Storage and handling Store at room temperature (25 °C/77 °F). Avoid excessive heat. Protect from freezing. Storage and handling"
      ],
      "warnings_and_cautions": [
        "Warnings and precoutions section See appropriate Operator’s Manual for additional information and complete usage instructions. Not for direct intravenous infusion Do not use unless solution is clear and no leaks detected Single use container. Discard unused portion Intended for use only with automated red cell washing and apheresis devices Store at room temperature. Avoid excessive heat. Protect from freezing",
        "Warnings and precoutions Not for direct intravenous infusion Do not use unless solution is clear and no leaks detected Single use container. Discard unused portion Intended for use only with automated red cell washing and apheresis devices See Operator’s Manual for additional information and complete usage instructions Store at room temperature. Avoid excessive heat. Protect from freezing"
      ],
      "description": [
        "ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 mL Each 100 mL contains: Citric Acid (Monohydrate), USP 0.042 g Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g Sodium Chloride, USP 0.410 g Adenine, USP 0.030 g Dextrose (Anhydrous), USP 1.000 g Sodium Citrate (Dihydrate), USP 0.588 g containing 15 mEq of Sodium. . Description",
        "Description of the product ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL Each 100 mL contains: Citric Acid (Monohydrate), USP 0.042 g Monobasic Sodium Phosphate (Monohydrate), USP 0.042 g Sodium Chloride, USP 0.410 g Adenine, USP 0.030 g Dextrose (Anhydrous), USP 1.000 g Sodium Citrate (Dihydrate), USP 0.588 g containing 15 mEq of Sodium. Description"
      ],
      "statement_of_identity": [
        "ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 ml Statement of identity",
        "Statement of idenity ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL Statement of identity"
      ],
      "recent_major_changes": [
        ""
      ],
      "package_label_principal_display_panel": [
        "Package label Manufacturer: GVS TM Inc. 1630 W Industrial Park St Covina, CA 91722, USA ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 mL Intended for use only with automated red cell washing devices and automated red cell apheresis devices. See appropriate Operator’s Manual for additional information and complete usage instructions. Each 100 mL contains: Citric Acid (Monohydrate), USP 0.042 g Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g Sodium Chloride, USP 0.410 g Adenine, USP 0.030 g Dextrose (Anhydrous), USP 1.000 g Sodium Citrate (Dihydrate), USP 0.588 g containing 15 mEq of Sodium. 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 symbol: 0462A-00 LOT symbol expiry date symbol template revision number: 126618-00 REV.0 Package label",
        "Package label Manufacturer: GVS TM Inc. 1630 W Industrial Park St Covina, CA 91722, USA ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL Intended for use only with automated red cell apheresis devices. See appropriate Operator’s Manual for additional information and complete usage instructions. Each 100 mL contains: Citric Acid (Monohydrate), USP 0.042 g Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g Sodium Chloride, USP 0.410 g Adenine, USP 0.030 g Dextrose (Anhydrous), USP 1.000 g Sodium Citrate (Dihydrate), USP 0.588 g containing 15 mEq of Sodium. 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 symbol: 0460A-00 LOT symbol expiry date symbol template revision number 126617-00 REV.0 Package label"
      ],
      "set_id": "3dfa3397-fc13-4659-e063-6394a90a5abc",
      "id": "42ecbc27-e538-a151-e063-6394a90ad89e",
      "effective_time": "20251106",
      "version": "2",
      "openfda": {
        "application_number": [
          "BN820915"
        ],
        "brand_name": [
          "AS-3"
        ],
        "generic_name": [
          "AS-3"
        ],
        "manufacturer_name": [
          "GVS TM INC"
        ],
        "product_ndc": [
          "87069-460",
          "87069-462"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ADENINE",
          "DEXTROSE, UNSPECIFIED FORM"
        ],
        "spl_id": [
          "42ecbc27-e538-a151-e063-6394a90ad89e"
        ],
        "spl_set_id": [
          "3dfa3397-fc13-4659-e063-6394a90a5abc"
        ],
        "package_ndc": [
          "87069-460-42",
          "87069-462-33"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "JAC85A2161",
          "IY9XDZ35W2"
        ]
      }
    }
  ]
}