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HemoTemp II 3000

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 NumberM74430001 UDI-DIDate8 Feb 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  • Withdrawn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
Generic Name
Medical product temperature point indicator, thermochemical
Model / Reference
3000
Primary DI / UDI-DI
M74430001
FDA Product Code
KSS
GMDN Term
Medical product temperature point indicator, thermochemical
Device Class
Class I
Regulation Number
864.9050
GUDID distribution status
Not in Commercial Distribution

Other devices from Biosynergy, Inc.

Properties

  • Single Use

Other properties (13)

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