Skip to content

Inito InTemp Basal Thermometer FDTH-V0-13

by Inito 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860015673107 UDI-DI Date8 Apr 2026ListedStatusListed 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  • Withdrawn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
Inito InTemp Basal Thermometer
Generic Name
Intermittent electronic patient thermometer
Model / Reference
FDTH-V0-13
Primary DI / UDI-DI
00860015673107
FDA Product Code
SDV
GMDN Term
Intermittent electronic patient thermometer
Device Class
Class II
Regulation Number
880.2910
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No