FDA.reportPublic FDA data

AlcoBreath Tube

Primary DI
G354AAB08402
Brand
AlcoBreath Tube
Company
Alcopro Inc.
Model
ABT08
Catalog number
AAB0840
Device description
Disposable breath alcohol test
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DJZDevices, Breath Trapping, Alcohol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJZDevices, Breath Trapping, AlcoholClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102225000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102225000ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TESTAlcopro, Inc.2011-04-06DJZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G354AAB08402PrimaryHIBCC0
G354AAB08400Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Alcohol breath analyserA portable, battery-powered instrument intended to measure and document alcohol concentrations in human breath at the point-of-care.

Regulatory Flags#

DUNS number
113044739
Device count
100

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G354AAB08201AlcoBreath TubeABT08AAB08202022-09-22
G354AAB15201AlcoBreath TubeABT15AAB15202022-09-22
G354AAB15402AlcoBreath TubeABT15AAB15402022-09-22
G354CCP024103CheckpointCP02CCP024102022-09-22
G354CCP042001CheckpointCP04CCP042002022-09-22
G354CCP044103CheckpointCP04CCP044102022-09-22
G354CCP082001CheckpointCP08CCP082002022-09-22
G354CCP084103CheckpointCP08CCP084102022-09-22
G354AAB08202AlcoBreath TubeABT08AAB08202022-09-22
G354AAB08400AlcoBreath TubeABT08AAB08402022-09-22
G354AAB15202AlcoBreath TubeABT15AAB15202022-09-22
G354AAB15400AlcoBreath TubeABT15AAB15402022-09-22
G354CCP022001CheckpointCP02CCP022002022-09-22
G354CCP024100CheckpointCP02CCP024102022-09-22
G354CCP042002CheckpointCP04CCP042002022-09-22
G354CCP044104CheckpointCP04CCP044102022-09-22
G354CCP082002CheckpointCP08CCP082002022-09-22
G354CCP084104CheckpointCP08CCP084102022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B90112SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2025-08-19
B90110SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2023-09-23
B90111SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2023-09-23
G354AAB08201AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB15201AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB15402AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354CCP024103CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP042001CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP044103CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP082001CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP084103CheckpointAlcopro Inc.DJZ2022-09-22
G354AAB08202AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB08400AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB15202AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB15400AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354CCP022001CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP024100CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP042002CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP044104CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP082002CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP084104CheckpointAlcopro Inc.DJZ2022-09-22
B90108SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2022-06-23
B90109SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2022-06-23
B90106SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-12-08
B90107SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-12-08
00853464001126AlcoMate CoreAK Globaltech CorpDJZ2021-06-21
B90101SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-04-07
B90102SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-04-07
B90103SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-04-07
B90104SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-04-07