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Hypothermia Management Set 03

by Safeguard Us Operating, LLC

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

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 NumberM68959120030 UDI-DI Date24 Oct 2025ListedStatusListed GUDID: 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  • Withdrawn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
Hypothermia Management Set
Generic Name
Hypothermia-prevention whole-body suit
Model / Ref / Catalog
03, 59-120
Primary DI / UDI-DI
M68959120030
FDA Product Code
KME, IMD
GMDN Term
Hypothermia-prevention whole-body suit
Device Class
Class I
Regulation Number
880.6060, 890.5710
GUDID distribution status
In Commercial Distribution

Other devices from Safeguard Us Operating, LLC

See all devices from Safeguard Us Operating, LLC →

Properties

  • Single Use
  • Convenience Kit
  • Premarket Exempt

Other properties (11)

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