CPDA-1 by is a Prescription medication manufactured, distributed, or labeled by Fenwal, Inc.. Drug facts, warnings, and ingredients follow.
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:
Note: In difficult collection conditions (e.g. slow blood flow), leave the needle guard disengaged, behind the hub during collection. Engage the needle guard at the end of blood collection.
Precaution: Do not proceed with the remaining steps until the entire whole blood unit is collected.
Precaution: Complete steps 13 - 22 within approximately 4 minutes after sealing the donor tubing to avoid possible clot formation in the tubing.
Note: If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon insertion to avoid barrel detaching from Luer.
Notes:
Precaution: When replacing the access device, be careful to avoid contact with any blood droplets on the Luer or Sampling Site. Discard used access device appropriately
Precaution: The needle guard must be held stationary while the needle is withdrawn into it.
Note: Step 22 may be performed prior to step 21 if desired.
Filtration Procedure:
Note: The time of whole blood filtration may vary depending on processing option selected.
Note: The storage container must remain below the level of the filter during filtration.
Note: Manual or mechanical pressure should not be used to increase the flow rate through the filter.
Note: Tubing below the filter should not be stripped at any time during the filtration process.
Note: If the filtration of whole blood is initiated at ambient temperature and not completed within 8 hours after blood collection, then filtration should be completed between 1 and 6°C.
Note: If a QC sample is desired, thoroughly mix the filtered whole blood and strip the donor segment tubing. Use the last segment (or segments) as the QC sample.
Component Preparation Procedure:
Note: Platelet concentrates are not intended to be made with this product.
Note: Fresh frozen plasma should be separated from the red blood cells and placed in the freezer at -18°C or colder within 8 hours after blood collection.
Store at Controlled Room Temperature.
USP Definition of “Controlled Room Temperature”
United States Pharmacopeia, General Notices.
United States Pharmacopeial Convention, Inc.
12601 Twinbrook Parkway, Rockville, MD
FENWAL, BLOOD-PACK and TRANSFER PACK are trademarks of Fenwal, Inc.
SEPACELL is a trademark of Asahi Kasei Medical Co., Ltd.
DONORCARE is a trademark of ITL Corporation.
© 2010 Fenwal, Inc. All rights reserved.
– Manufacturer
Fenwal, Inc.
Lake Zurich, IL 60047 USA
Made in USA
1-800-933-6925
07-19-04-639 REV: A 03/2010
Code 4R3301
12 Units
Fenwal™
Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack™ Unit; Integral Sepacell RS-2000 Whole Blood Leukocyte Reduction Filter
Double For Collection of 450 mL Blood
Y-Sampling Site, DonorCare Needle Guard, 16 ga. Ultra Thin Wall Needle
Rx only
Each unit consists of a PL 146 Plastic primary container with 63 mL of CPDA-1 solution containing 2 g Dextrose (monohydrate) USP, 1.66 g Sodium Citrate (dihydrate) USP, 188 mg Citric Acid (anhydrous) USP, 140 mg Monobasic Sodium Phosphate (monohydrate) USP and 17.3 mg Adenine USP, pH may have been adjusted with sodium hydroxide; an integral RS-2000 filter with one empty 450 mL PL 146 Plastic container forred cell storage and one empty 400 mL PL 146 Plastic Transfer Pack™ container.
Sterile, nonpyrogenic fluid path
See instructions for use.
Store at Controlled Room Temperature (refer to direction insert).
U.S Pat. Nos. RE 35,804; 5,314,421; 5,372,143; 5,507,525; 6,132,413; pat. pend.
FENWAL, BLOOD-PACK, and TRANSFER PACK are trademarks of Fenwal, Inc.
PL 146 is a trademark of Baxter International, Inc.
Sepacell is a registered trademark of Asahi Kasei Medical Co., Ltd.
DonorCare is a trademark of ITL Corporation
Fenwal, Inc.
Lake Zurich, IL 60047 USA
Made in USA
07-28-02-794 REV: A.
CPDA-1
anticoagulant citrate phosphate dextrose adenine solution |
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Labeler - Fenwal, Inc. (794519020) |