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HemoTemp II Activator 9000

by Biosynergy, Inc.

Listed FDA GUDID listing, not in commercial distribution

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM74490000 UDI-DIDate1 Jun 2017ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
HemoTemp II Activator
Generic Name
Heating block IVD
Model / Reference
9000
Primary DI / UDI-DI
M74490000
FDA Product Code
JRG
GMDN Term
Heating block IVD
Device Class
Class I
Regulation Number
862.2050
GUDID distribution status
Not in Commercial Distribution

Other devices from Biosynergy, Inc.

Properties

  • Premarket Exempt
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No