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Carbon Monoxide Breath Sensor FP-20021

by Carrot Inc. Which Will Do Business in California As Carrot Behavioral Health Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00863571000301 UDI-DI Date27 Oct 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Carbon Monoxide Breath Sensor
Generic Name
Carbon monoxide breath analyser
Model / Reference
FP-20021
Primary DI / UDI-DI
00863571000301
510(k) Number
FDA Product Code
CCJ
GMDN Term
Carbon monoxide breath analyser
Device Class
Class II
Regulation Number
868.1430
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K171408)

Other devices from Carrot Inc. Which Will Do Business in California As Carrot Behavioral Health Inc.

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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