ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC) (anticoagulant citrate phosphate dextrose- cpd

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL), Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL), Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)

可用日期:

Fenwal, Inc.

处方类型:

PRESCRIPTION DRUG

授权状态:

New Drug Application

产品特点

ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL
146 PLASTIC)- ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION
AND ADSOL PRESERVATION
SOLUTION
FENWAL, INC.
----------
BLOOD-PACK™ UNIT WITH AN INTEGRAL SEPACELL™ RS-2000 WHOLE BLOOD
LEUKOCYTE
REDUCTION FILTER FOR COLLECTION AND FILTRATION OF WHOLE BLOOD USING
CPD/ADSOL™ RED CELL
PRESERVATION SOLUTION
RX ONLY
Contains Y-Sampling Site for the collection of unanticoagulated whole
blood samples for laboratory
testing and the DONORCARE™ Needle Guard.
Integral filter unit intended for leukocyte reduction of whole blood
up to 8 hours after blood collection
when whole blood is stored at ambient temperature or up to 72 hours
after blood collection when whole
blood is refrigerated. The leukocyte reduced blood products may then
be stored for the maximum
allowable dating period.
INSTRUCTIONS FOR USE
COLLECTION PROCEDURE:
USE ASEPTIC TECHNIQUE.
NOTE: Nominal tubing dimensions of product are 0.118” inner diameter
x 0.025” wall thickness.
NOTE: If the Y-Sampling Site is not used, donor samples may be
collected using an alternate method
following standard procedures.
PRECAUTIONS :
1.
2.
3.
4.
5.
6.
7.
8.
NOTE: In difficult collection conditions (e.g. slow blood flow), leave
the needle guard disengaged,
DO NOT USE UNLESS THE SOLUTIONS ARE CLEAR.
BEFORE BEGINNING PROCEDURE, OBTAIN ONE ACCESS DEVICE FOR EACH
BLOOD-PACK™ UNIT WITH
Y-SAMPLING SITE TO BE PROCESSED.
Identify BLOOD-PACK unit using appropriate donor identification
system.
Adjust donor scale to desired collection weight and position primary
container on the donor scale
as far as possible below donor arm.
Clamp donor tubing between needle and Y-Sampling Site with hemostat.
This step may be
performed prior to step 1 or 2.
Apply pressure to donor’s arm and disinfect site of venipuncture.
If blood pressure cuff is used, inflate to approximately 60 mmHg.
Remove needle cover per instructions below:
a)
b)
Holding the hub and cover near the tamper-evident seal, twist cover
1/4 turn to bre