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Pivot Breath Sensor

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
Pivot Breath Sensor FDA UDI
Generic Name
Carbon monoxide breath analyser FDA UDI
Model / Reference
PFP-20300 FDA UDI

Identifiers

Primary DI / UDI-DI
00863571000318 FDA UDI
510(k) Number
K171408 FDA UDI
FDA Product Code
CCJ FDA UDI
GMDN Term
Carbon monoxide breath analyser FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1430 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Carbon monoxide breath analyser

Pivot Breath Sensor by Carrot Inc. Which Will Do Business In California As Carrot Behavioral Health Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Carbon monoxide breath analyser.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carrot Inc. Which Will Do Business In California As Carrot Behavioral Health Inc.

Sources (1)

  • FDA UDI fd1c7aeb-41a0-41ee-b465-837eabf9d588 34 fields · synced Jun 1, 2026