FDA.reportPublic FDA data

Checkpoint

Primary DI
G354CCP024100
Brand
Checkpoint
Company
Alcopro Inc.
Model
CP02
Catalog number
CCP02410
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
Rx
false
OTC
true
Sterile
false
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
G354CCP024104PackageHIBCC500In Commercial Distribution
G354CCP024103PrimaryHIBCC0
G354CCP024100Unit 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113044739
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G354AAB08201AlcoBreath TubeABT08AAB08202022-09-22
G354AAB08402AlcoBreath TubeABT08AAB08402022-09-22
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
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
G354AAB08402AlcoBreath 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
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