FDA UDI In Commercial Distribution 🇺🇸 United States

Checkpoint

DI: G354CCP024103 · Model: CP02 · Alcopro Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

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Basic Information

Brand Name
Checkpoint
Primary DI
G354CCP024103
Version / Model
CP02
Catalog Number
CCP02410
Company Name
Alcopro Inc.
Labeler DUNS
113044739
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2022-09-22
Public Version
1
Public Version Date
2022-09-30
Public Version Status
New
Public Device Record Key
359dd84a-7719-4d2e-b808-3481f5673923

Device Description

Disposable breath alcohol test

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DJZ Devices, Breath Trapping, Alcohol

GMDN Terms

Code Name
36041 Alcohol breath analyser

Identifiers

Type ID
Unit of Use G354CCP024100
Primary G354CCP024103
Package G354CCP024104

Premarket Submissions

Submission Number Supplement Number
K102225 000