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AlcoBreath Tube

FDA UDI

Class I (US FDA UDI)

by Alcopro, Inc.

Identity

Trade Name
AlcoBreath Tube FDA UDI
Generic Name
Alcohol breath analyser FDA UDI
Device Name
Disposable breath alcohol test FDA UDI
Model / Reference
ABT15 FDA UDI
Description
Disposable breath alcohol test FDA UDI

Identifiers

Catalog Number
AAB1540 FDA UDI
Primary DI / UDI-DI
G354AAB15402 FDA UDI
510(k) Number
K102225 FDA UDI
FDA Product Code
DJZ FDA UDI
GMDN Term
Alcohol breath analyser FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Alcohol breath analyser

AlcoBreath Tube by Alcopro, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alcohol breath analyser.

Cleared under the same submission

K102225 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alcopro, Inc.

Sources (1)

  • FDA UDI 25e171a1-fcac-4307-b8a6-9593116c1d13 35 fields · synced May 30, 2026