Data from FDA - Curated by EPG Health - Last updated 27 July 2017

Indication(s)

INDICATIONS AND USAGE For collection of up to 210 ml of umbilical cord blood. Use aseptic technique. Sterile Exterior Contents inside overwrap pouch, within the foil envelope, are sterile and acceptable for use in a sterile field if pouch is unopened and undamaged; visual inspection to confirm the integrity of overwrap pouch should be performed.

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Advisory information

Special warnings and precautions
GENERAL PRECAUTIONS Do not use if the package is damaged or seal is incomplete. Use only if solution is clear. Sealing should be done in a manner that avoids fluid splatter. Always dispose of blood-contaminated products in a manner consistent with established BIOHAZARD safety procedures.

More information

Category Value
Authorisation number NDA800222
Agency product number 593YOG76RN
Orphan designation No
Product NDC 62646-791
Date Last Revised 09-03-2011
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Medsep Corporation