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TempTouch IM1

by Mr3 Health, Inc.

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 NumberG518TTIM112300150000101 UDI-DI Date24 Oct 2023ListedStatusListed 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  • Withdrawn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
TempTouch
Generic Name
Infrared patient thermometer, skin
Model / Reference
IM1
Primary DI / UDI-DI
G518TTIM112300150000101
FDA Product Code
FLL
GMDN Term
Infrared patient thermometer, skin
Device Class
Class II
Regulation Number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infrared patient thermometer, skin

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number

Other properties (10)

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