Acd-A (Anticoagulant Citrate Dextrose Solution A) Solution [Haemonetics Manufacturing Inc] -

ACD-A (ANTICOAGULANT CITRATE DEXTROSE SOLUTION A) SOLUTION [HAEMONETICS MANUFACTURING INC]
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NDC	53157-796-08
Set ID	ec28b740-2fd1-453e-9ee9-1aa20d223d6c
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	Haemonetics Manufacturing Inc
Generic Name
Product Class	Anti-coagulant
Product Number
Application Number	NDA710497

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DESCRIPTION

Re-Order Product Code: 796-08

750 mL volume. Single use container.

Sterile, nonpyrogenic fluid path. Sterilized by steam.

Store at room temperature.
INDICATIONS AND USAGE

For use with automated pheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for pheresis only.
CONTRAINDICATIONS

Not for direct intravenous infusion.
WARNINGS

Avoid excessive heat. Protect from freezing.
PRECAUTIONS

Do not use unless solution is clear and no leaks detected.

General

Rx only. Discard unused portion.

Recommended Storage: Store at room temperature (25°C / 77°F).
HOW SUPPLIED

750 mL volume bag.

Each 100 ml contains:

0.73 g citric acid (anhydrous), USP

2.20 g sodium citrate (dihydrate), USP

2.45 g dextrose (monohydrate), USP
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Hot Stamped Bag

Envelope Label
References

HAEMONETICS and THE Blood Management Company are trademarks of Haemonetics Corporation.

Manufactured for:

Haemonetics Corporation

400 Wood Road

Braintree, MA 02184, USA

By: Haemonetics Manufacturing Inc.

1630 Industrial Park Street

Covina, CA 91722, USA

INGREDIENTS AND APPEARANCE

ACD-A
anticoagulant citrate dextrose solution a solution

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	2.45 g in 100 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	SODIUM CITRATE	2.20 g in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	0.73 g in 100 mL

#	Item Code	Package Description
Packaging
1	NDC:53157-796-08	12 in 1 CARTON
1		750 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA710497	11/06/1987

Labeler - Haemonetics Manufacturing Inc (078598396)

Registrant - Haemonetics Manufacturing Inc (078598396)

Name	Address	ID/FEI	Business Operations
Establishment
Haemonetics Manufacturing Inc		078598396	MANUFACTURE(53157-796)

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