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CPD/ADSOL™ BLOOD-PACK™ Unit Quadruple OPTIPAC™ Opti-System | ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) [Fenwal, Inc.] | BioPortfolio

12:27 EST 27th January 2019 | BioPortfolio

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Rx Only

Opti-System

Use aseptic technique

Caution: Do not use unless the solutions are clear.

For further processing, use standard techniques for component processing.

Sterile, non-pyrogenic fluid path. Sterilized by steam. Single use only. Dispose of container appropriately.

Store at Controlled Room TemperatureUSP Definition of “Controlled Room Temperature”United States Pharmacopeia, General Notices.United States Pharmacopeial Convention, Inc.12601 Twinbrook Parkway, Rockville, MD

Manufactured by: Fenwal International, Inc. Road 357, Km. 0.8Maricao, PR 00606

Made in USA

07-19-05-015    REV: A07/2010

Imported and distributed in Indonesia by: PT.Medquest Jaya Global Menara Salemba 6th FloorJl.Salemba Raya Kav 5-5AJakarta-Indonesia 10440Reg. No.: DEPKES RI AKL 20209902359

Imported and distributed in Thailand by: Fenwal (Thailand) Ltd. 17th Fl. Thanapoom Tower1550 New Petchburi Rd., MakasanRajthevi, Bangkok 10400ThailandReg. No.:

Imported and distributed in Philippines by: Medlink Marketing Unit 404 Vicar’s Building,No.31 Visayas Ave.,Vasra, Quezon City 1100PhilippinesReg. No.: DVR-5805

– Manufacturer

FENWAL, ADSOL, BLOOD-PACK, OPTIPAC and OPTIPRESS are trademarks of Fenwal, Inc.

© 2010 Fenwal, Inc. All rights reserved.

Code: A4R7473

3 Units

Fenwal™

CPD/ADSOL™ BLOOD-PACK™ Unit Quadruple OPTIPAC™ Opti-System

Rx only

Each unit consists of a PL 146 bag containing 63 mL of Citrate, Phosphate and Dextrose Anticoagulant Solution (CPD) with 450 mL of capacity; a PL 146 transfer pack containing 100 mL of Adenine, Dextrose and Mannitol Solution (ADSOL), 450 mL of capacity; and two PL 1240 transfer packs, 400 mL of capacity.

Each 63 mL of CPD solution contains: 1.66 g, Sodium citrate (dihydrate), USP, 1.61 g Dextrose (monohydrate), USP, 188 mg Citric acid (anhydrous), USP, 140 mg Monobasic sodium phosphate (monohydrate), USP. Water for Injection USP to 63 mL.

Each 100 mL of ADSOL solution contain: Sodium chloride, USP, 900 mg, Dextrose monohydrate, USP, 2.20 g, Adenine, USP, 27.0 mg, Mannitol, USP, 750 mg. Water for Injection USP to 100 mL.

See instructions for use. Sterile, non-pyrogenic fluid path. Steam sterilized. Single use only. Do not vent. Do not use if there is any visible sign of deterioration. Dispose of container appropriately.

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

Unused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture.

Direct handling of product surfaces prior to extended storage in the foil pouch may result in mold growth.

Units removed from the foil pouch must be used within 4 days (96 hours). Units out of the foil pouch for longer than 4 days must be discarded.

Manufactured by: Fenwal International, Inc. Road 357, Km. 0.8Maricao, PR 00606

Made In USA

Imported and distributed in Philippines by: Medlink Marketing Unit 404 Vicar’s Building,No.31 Visayas Ave.,Vasra, Quezon City 1100PhilippinesReg No.: DVR-5805

Imported and distributed in Indonesia by: PT.Medquest Jaya Global Menara Salemba 6th FloorJl.Salemba Raya Kav 5-5AJakarta-Indonesia 10440Reg No.: DEPKES RI AKL 20209902359

FENWAL, BLOOD-PACK, OPTIPAC and ADSOL are trademarks of Fenwal, Inc.

07-28-05-041   REV: A

Lot:

Exp. Date:

Manufacturer

Fenwal, Inc.

Active Ingredients

Source

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