ANTICOAGULANT SODIUM CITRATE- sodium citrate solution 
Medsep Corporation

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Anticoagulant Sodium Citrate Solution, USP
Code 798-60

ANTICOAGULANT SODIUM CITRATE SOLUTION, USP

Sterile, non-pyrogenic fluid path. Sterilized by steam.

Rx only.

250 ml volume bag.

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.

WARNINGS

Not for direct intravenous infusion.

DO NOT VENT.

Avoid excessive heat. Protect from freezing.

GENERAL PRECAUTIONS

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

Discard unused portion.

HOW SUPPLIED

Single Use Container.

INFORMATION FOR PATIENTS

Medsep Corporation, A Subsidiary of Pall Corp., Covina, CA 91722, USA

Visit us at www.pall.com/medical

For Pall customer service, call: 1.800.645.6578

CONTAINER TEXT DISPLAYED

Sodium Citrate Bag Text

Anticoagulant Sodium Citrate Bag Text

ANTICOAGULANT SODIUM CITRATE SOLUTION, USP

250 mL Code 798-60

For use with automated plasmapheresis equipment only. Each 250 mL of anticoagulant contains 10.0 g sodium citrate (dihydrate), USP (pH adjusted with citric acid, USP).

CAUTION: Not for direct intravenous infusion.

Do not use unless anticoagulant is clear. This unit should be used for plasmapheresis only. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx Only.

DO NOT VENT.

Issued August 2010, 147798603

ANTICOAGULANT SODIUM CITRATE 
sodium citrate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62646-798
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CITRATE (UNII: 1Q73Q2JULR) (CITRIC ACID ANHYDROUS - UNII:XF417D3PSL) SODIUM CITRATE10 g  in 250 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62646-798-60250 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA76030504/15/2011
Labeler - Medsep Corporation (928224765)
Registrant - Medsep Corporation (928224765)
Establishment
NameAddressID/FEIBusiness Operations
Medsep Corporation928224765manufacture, relabel, repack

Revised: 5/2011
Document Id: a083fb8e-3012-4d12-94d3-949a3188aba3
Set id: 3a8dfcfa-e034-40ca-a71f-05099015f87d
Version: 4
Effective Time: 20110520
 
Medsep Corporation