• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device cryogenic cord blood storage container
Regulation Description Cord blood processing system and storage container.
Definition Intended as a final container for the cryopreservation and the storage of cord blood products.A cryogenic cord blood storage container is a flexible ethylene vinyl acetate (eva) or similar polymer bag intended as a final container for cryopreservation and storage of cord blood products in the liquid or vapor phases of liquid nitrogen.
Physical State Consists of flexible ethylene vinyl acetate (EVA) or similar polymer bag. May include sterile fluid path and access ports and is designed to withstand freezing in the liquid and vapor phases of liquid nitrogen.
Technical Method Acts as a physical container for cord blood products, and is designed to withstand freezing in the liquid and vapor phases of liquid nitrogen
Target Area Cord blood is collected from neonatal umbilical cord and stored for later infusion, injection or transplantation
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeOOF
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 864.9900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-