LEUKOTRAP WB SYSTEM- cpda-1 blood bag collection system solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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)

可用日期:

Haemonetics Corporation

INN（国际名称）:

DEXTROSE MONOHYDRATE

组成:

DEXTROSE MONOHYDRATE 2.23 g in 70 mL

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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.

產品總結:

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.

授权状态:

New Drug Application

产品特点

LEUKOTRAP WB SYSTEM- CPDA-1 BLOOD BAG COLLECTION SYSTEM SOLUTION
HAEMONETICS CORPORATION
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LEUKOTRAP WB SYSTEM, CPDA-1 BLOOD COLLECTION SET WITH WBF2 FILTER AND
SAMPLING SYSTEM
DESCRIPTION
CPDA-1 Blood Collection Set, Double 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