SODIUM CITRATE- anticoagulant s odium citrate s olution s olution

Haemonetics Manufacturing Inc

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Anticoagulant Sodium Citrate Solution, USP

DESCRIPTION
Re-Order Product Code: 798-60
250 mL volume. Single use container.
Sterile, nonpyrogenic fluid path. Sterilized by steam.
Store at room temperature.

INDICATIONS AND USAGE

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

CONTRAINDICATIONS
Not for direct intravenous infusion.

WARNINGS
Avoid excessive heat. Protect from freezing. Do NOT vent.

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
250 mL volume bag.
Each 250 ml contains:
10.0 g sodium citrate (dihydrate), USP

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Bag Label
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

SODIUM CITRATE
anticoagulant sodium citrate solution solution
 Product Information
Prod uct T yp e HUMAN PRESCRIPTIO N DRUG Ite m Cod e (S ource ) NDC:53157-79 8

Route of Ad minis tration INTRAVENO US DEA S che d ule CII

Active Ing redient/Active Moiety

Ing redient Name Basis o f Streng th Streng th
SO DIUM CITRATE (UNII: 1Q 73Q 2JULR) (ANHYDRO US CITRIC ACID - UNII:XF417D3PSL) SO DIUM CITRATE 10 .0 g in 250 mL

Packag ing
# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
1 NDC:53157-79 8 -6 0 36 in 1 CARTO N
1 250 mL in 1 BAG; Type 0 : No t a Co mbina tio n Pro duc t

Marketing Information
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
NDA NDA76 0 30 5 0 6 /30 /19 78

Labeler - Haemonetics Manufacturing Inc (078598396)

Registrant - Haemonetics Manufacturing Inc (078598396)

Establishment
Name Ad d re s s ID/FEI Bus ine s s Op e rations
Ha e mo ne tic s Ma nufa c turing Inc 0 78 59 8 39 6 MANUFACTURE(53157-79 8 ) , STERILIZE(53157-79 8 ) , LABEL(53157-79 8 )

Revised: 2/2015 Haemonetics Manufacturing Inc