Caution
Not for preparation of blood products for transfusion or for direct intravenous infusion.
Anticoagulant Citrate Dextrose A Acd-a Injection, Solution
FDA Label NDC 43203-852
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Arteriocyte Medical Systems, Inc. for the product Anticoagulant Citrate Dextrose A Acd-a (NDC 43203-852). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding caution, recommended storage, each 10ml contains, other, principal display panel - 50 ml bag label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Recommended Storage
Room temperature (68° to 77°F, 20° to 25°C)
Avoid excessive heat. Protect from freezing.
Each 10Ml Contains
| Citric Acid Monohydrate USP | 0.08 g |
| Sodium Citrate Dihydrate USP | 0.220 g |
| Dextrose Monohydrate USP | 0.245 g |
| In Water for Injection USP |
Other
Manufactured for Arteriocyte Medical Systems, Inc.
45 South Street, Hopkinton, MA., 01748
by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.
ARTERIOCYTE
CELLULAR THERAPIES
MEDICAL SYSTEMS
Lot
Expiry Date
Principal Display Panel - 50 Ml Bag Label
Anticoagulant Citrate Dextrose Solution,
Solution A USP ACD-A
50 mL
Catalog # AMSACD-A
Anticoagulant intended for use only with devices that prepare Platelet Rich
Plasma (PRP) products for extracorporeal use. See Operator's Manuals for
additional information and complete usage instructions.
Sterile. Non-pyrogenic. Do not use unless the solution is clear and the
container is intact and undamaged. Rx only. Single use container.
Caution: Not for preparation of blood products for transfusion or for direct
intravenous infusion.
Storage Conditions: Room temperature (68° to 77°F, 20° to 25°C)
Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
| Each 10mL contains: | |
| Citric Acid Monohydrate USP | 0.08 g |
| Sodium Citrate Dihydrate USP | 0.220 g |
| Dextrose Monohydrate USP | 0.245 g |
| In Water for Injection USP | |
Manufactured for Arteriocyte Medical Systems, Inc.
45 South Street, Hopkinton, MA., 01748
by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.
ARTERIOCYTE
CELLULAR THERAPIES
MEDICAL SYSTEMS
Lot
Expiry Date
Principal Display Panel (50 mL Bag Label)
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