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
Indicated for collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction. Platelet concentrates are not intended to be made with this product.
Each shipping case contains 6 foil envelopes. Within each foil envelope resides 3 units of the collection system. Each unit consists of a collection bag with 70 ml of CPDA-1 solution and two empty bags.
New Drug Application
LEUKOTRAP WB SYSTEM- CPDA-1 BLOOD BAG COLLECTION SYSTEM SOLUTION HAEMONETICS CORPORATION ---------- LEUKOTRAP WB SYSTEM, CPDA-1 BLOOD COLLECTION SET WITH WBF2 FILTER AND SAMPLING SYSTEM DESCRIPTION CPDA-1 Blood Collection Set, Triple Bag with WBF2 Filter and 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 Indicated for collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction. Platelet concentrates are not intended to be made with this product. 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. 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 Leukotrap WB System with CPDA-1. 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 Sampling Site. 3. Secure donor tubing above the Y connector and disinfect site of phlebotomy. 4. If using blood pressure cuff, inflate to not more than 60 mm Hg. 5. Remove donor needle cover and accomplish phlebot 阅读完整的文件