ADSOL RED CELL PRESERVATION (anticoagulant citrate phosphate dextrose- cpd and adsol preservation kit kit

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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)

Boleh didapati daripada:

Fenwal, Inc.

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

New Drug Application

Ciri produk

ADSOL RED CELL PRESERVATION- ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE
(CPD) AND
ADSOL PRESERVATION KIT
FENWAL, INC.
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CPD/ADSOL- ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND ADSOL
PRESERVATION
BLOOD-PACK UNIT
BLOOD-PACK UNIT WITH AN INTEGRAL BIOFLEX RC LEUKOCYTE REDUCTION FILTER
USING CPD/ADSOL RED
CELL PRESERVATION SOLUTION FOR WHOLE BLOOD COLLECTION AND FILTRATION
OF RED BLOOD CELLS
RX ONLY
Contains Y-Sampling Site for the collection of unanticoagulated whole
blood samples for laboratory
testing.
Integral filter unit intended for leukocyte reduction of AS-1 red
blood cells:
At ambient temperature up to 8 hours after blood collection.
At refrigerated temperature up to 3 days after blood collection if
AS-1 red blood cells are prepared
within 3 days after whole blood collection.
The leukocyte reduced red blood cells may then be stored for the
maximum allowable dating period.
INSTRUCTIONS FOR USE
COLLECTION PROCEDURE:
USE ASEPTIC TECHNIQUE.
NOTES :
If the Y-Sampling Site is not used, donor samples may be collected
using an alternate method
following standard procedures.
Nominal tubing dimensions of product are 0.118" inner diameter x
0.025" wall thickness.
PRECAUTIONS:
UPON REMOVAL OF BLOOD-PACK UNIT FROM THE CLEAR PLASTIC OVERWRAP,
VISUALLY INSPECT THE UNIT.
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.
1. Identify Blood-Pack Unit using appropriate donor identification
system.
2. Adjust donor scale to desired collection weight and position
primary container on the donor scale as
far as possible below donor arm.
3. Clamp donor tubing between needle and primary container. (This step
may be performed prior to step
1 or 2.)
4. Following blood center procedures, apply pressure to donor’s arm
and disinfect site of venipuncture.
5. Remove needle cover per instructions below:
a) Holding the hub and cover near the tamper-evident seal, twist cover
and hub in opposite directions to
break seal.
b)