国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL, SODIUM CATION - UNII:LYR4M0NH37), CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37), ADENINE (UNII: JAC85A2161) (ADENINE - UNII:JAC85A2161)
Haemonetics Corporation
INTRAVENOUS
PRESCRIPTION DRUG
For collection of blood and preparation of red blood cells, plasma and platelets. Platelets are not intended to be produced when using ‘doubles’ .
Each shipping case contains 8 foil envelopes. Within each foil envelope resides 3 units of the collection system. Each unit consists of a collection bag with 63 ml of CPDA-1 solution and one empty bag.
New Drug Application
CPDA-1 BLOOD COLLECTION SYSTEM- BLOOD COLLECTION SYSTEM SOLUTION HAEMONETICS CORPORATION ---------- CPDA-1 BLOOD COLLECTION SET WITH SAMPLING SYSTEM DESCRIPTION CPDA-1 Blood Collection Set with Sampling System Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached Samp _Lok_® Vacuum Tube Holder). Refer to unit foil package label for specific product description being used. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx only. This product is free of natural rubber latex. INDICATIONS AND USAGE For collection of blood and preparation of red blood cells, plasma and platelets. Platelets are not intended to be produced when using ‘doubles’ . WARNINGS Failure to achieve and maintain a closed system during processing would result in a product that must be transfused within 24 hours. GENERALPRECAUTIONS Use Aseptic Technique. Use only if solution is clear. If preparing a platelet concentrate, the platelet-rich plasma should be separated from the red blood cells within 8 hours after blood collection. If preparing fresh frozen plasma, separate from the red blood cells and place in the freezer at -18 °C or colder within 8 hours after collection. Store CPDA-1 preserved red blood cells at 1—6 °C for up to 35 days and use as indicated. * During processing, always observe the following precautions: 1. Sealing should be done in a manner that avoids fluid splatter. 2. Always dispose of blood-contaminated products in a manner consistent with established BIOHAZARD safety procedures. ADVERSE REACTIONS There are no known potential adverse reactions associated specifically with the CPDA-1 Blood Collection Set with Sampling System. I. BLOOD COLLECTION INSTRUCTIONS FOR SYSTEMS CONTAINING A Y SAMPLING SITE (YSS) ONLY 1. Load blood agitation device or suspend blood bag on donor scale and adjust donor scale to desired collection gross weight as per manufacturer's instructions. 2. Clamp donor tubing between the Donor _Care_® Needle Guard (DCNG) and Y Sa 阅读完整的文件