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ACD-A Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., PN 9350, 30 mL NDC 23731-6051-3 | Anticoagulant Citrate Dextrose A [Citra Labs] | BioPortfolio

13:15 EST 27th January 2019 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A), is a sterile, non-pyrogenic solution of citric acid, sodium citrate, and dextrose, in water for injection. Each 10 mL of solution contains:

Single patient use only, on a single occasion.

Citric Acid, anhydrous, USP 0.073 g
Sodium Citrate, dihydrate, USP 0.220 g
Dextrose, monohydrate, USP 0.245 g
Water for Injection, USP q.s.
pH: 4.5 – 5.5

ACD-A acts as an anticoagulant by the action of the citrate ion chelating free ionized calcium, thus making calcium unavailable to the coagulation system.

Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P. (ACD-A), is intended for use as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.

NOT FOR DIRECT INTRAVENOUS INFUSION

NOT FOR DIRECT INTRAVENOUS INFUSION

None.

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ACD-A.

Long-term studies in animals have not been performed to evaluate the effects of ACD- A on pregnant women.

The safety and effectiveness of ACD-A in children have not been established.

Not applicable. This product is used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP).

Not applicable. This product is used as an anticoagulant in the extracorporeal blood processing with Autologous PRP systems in production of platelet rich plasma (PRP).

Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.

Caution: Federal Law (US) restricts this devise to sale by or on the order of a Physician.

Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A)

  REF SIZE CASE
  PN 9350-10 30 mL 10 Vials/Case
  PN 9350-25 30 mL 25 Vials/Case

It is recommended that the product be stored at ambient room temperature, 24 °C (75 °F); however, the product can be stored between 15 °C (59 °F) and 30 °C (86 °F). Protect from freezing and exposure to excessive heat should be minimized.

Manufactured & Distributed by: Citra Labs™ 55 Messina Drive, Braintree, MA 02184 Phone Number: 1-800-299-3411

Authorized Representative: Biomet U.K. Ltd. Waterton Industrial Estate Bridgend, South Wales, CF31 3XA Great Britain United Kingdom Phone 441.65.66.55.221

C E

ACD-A Anticoagulant Citrate Dextrose Solution, 10 Vials / Case Solution A, U.S.P., ACD-A, 30 mL

REF PN 9350-10 WARNING: NOT FOR DIRECT INTRAVENOUS INFUSION

Used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to PRP Systems manufacturer's Directions for Use.

Manufactured & Distributed by:

Citra Labs A Biomet Biologics Company

Citra Labs, LLC. 55 Messina Drive, Braintree, MA 02184 1-800-299-3411

EC REP Authorized Representative: Biomet U.K. Ltd., Waterton Industrial Estate Bridgend, South Wales, CF31 3XA Great Britain - United Kingdom Phone 441.65.66.55.221

STERILE • NON-PYROGENIC

Composition per 10 mL of Solution: Citric Acid, (Anhydrous), U.S.P. 0.073 g. Sodium Citrate, (Dihydrate), U.S.P. 0.220 g. Dextrose, (Monohydrate), U.S.P. 0.245 g. CAUTION: Single Procedure Use-Discard Unused Portion Do Not Use Unless Solution is Clear and Seal is Intact. Store Between 15 °C - 30 °C (59 °F - 86 °F). RX Only:

EXP DATE

LOT

LA9350-10B 02/15

Manufacturer

Citra Labs

Active Ingredients

Source

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