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PrepaCyte-CB 500 PCB500

by Cryo-Cell International, Inc.

PrepaCyte-CB 500 PCB500 is a Class II device made by Cryo-Cell International, Inc., listed in FDA GUDID since 21 Jan 2022 (UDI-DI 00861880000333), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00861880000333 UDI-DI Date21 Jan 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
PrepaCyte-CB 500
Generic name
Blood centrifugation system containment kit
Model / reference
PCB500
Primary DI / UDI-DI
00861880000333
FDA product code
OAO
GMDN term
Blood centrifugation system containment kit
Device class
Class II
Regulation number
864.9900
GUDID distribution status
In Commercial Distribution

Other devices from Cryo-Cell International, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)