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| ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) [Fenwal, Inc.] | BioPortfolio

12:30 EST 27th January 2019 | BioPortfolio

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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 AS-1 red blood cells:

The leukocyte reduced red blood cells 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:

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Precaution: The needle guard must be held stationary while the needle is withdrawn into it.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.

Component Preparation:

Notes:

Note: Steps 24 through 30 provide one method for centrifuge cup loading.

Filtration Procedure:

Precaution: Red blood cell products collected from certain donors may have extended filtration times and the potential for ineffective filtration and leukoreduction.

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, Inc. Lake Zurich, IL 60047 USA

Made in USA

1-800-933-6925

07-19-07-272    REV: A11/2012

Manufacturer

FENWAL, BLOOD-PACK, TRANSFER-PACK, ADSOL, and FLEX-EXCEL are trademarks of Fenwal, Inc.

SEPACELL is a trademark of Asahi Kasei Medical Co., Ltd.

DONORCARE is a trademark of ITL Corporation.

© 2012 Fenwal, Inc. All rights reserved.

Code 4R1584

10 Units

Fenwal™

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK™ Unit; TRANSFER-PACK™ Container with ADSOL™ Red Cell Preservation Solution; Integral SEPACELL™ FLEX-EXCEL™ Red Cell Leukocyte Reduction Filter

Triple For the Collection and Processing of 500 mL BloodY-Sampling Site, DONORCARE™ Needle Guard, 16 ga. Ultra Thin Wall Needle

Rx only

Each unit consists of a PL 146 Plastic primary container with 70 mL of CPD solution containing 1.84 g Sodium Citrate (dihydrate) USP, 1.78 g Dextrose (monohydrate) USP, 209 mg Citric Acid (anhydrous) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP, pH may have been adjusted with sodium hydroxide; one 400 mL PL 146 Plastic TRANSFER-PACK container with 110 mL of ADSOL Red Cell Preservation Solution containing 2.42 g Dextrose (monohydrate) USP, 990 mg Sodium Chloride USP, 825 mg Mannitol USP, 30 mg Adenine USP; one empty 400 mL PL 1240 Plastic TRANSFER-PACK container; one integral SEPACELL FLEX-EXCEL Red Cell Leukocyte Reduction Filter and one empty 450 mL PL 146 Plastic TRANSFER-PACK container for the storage of AS-1 red blood cells, leukocytes reduced.

Sterile, non-pyrogenic fluid pathSee instructions for use.

Store at Controlled Room Temperature (refer to direction insert).

FENWAL, BLOOD-PACK, ADSOL, TRANSFER-PACK and FLEX-EXCEL are trademarks of Fenwal, Inc.SEPACELL is a trademark of Asahi Kasei Medical Co., Ltd.DONORCARE is a trademark of ITL Corporation.

Fenwal, Inc. Lake Zurich, IL 60047 USAMade in USA07-28-05-513 REV: A

Manufacturer

Fenwal, Inc.

Active Ingredients

Source

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