DEVICE: Checkpoint (G354CCP044103)
Device Identifier (DI) Information
Checkpoint
CP04
In Commercial Distribution
CCP04410
Alcopro Inc.
CP04
In Commercial Distribution
CCP04410
Alcopro Inc.
Disposable breath alcohol test
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36041 | Alcohol breath analyser |
A portable, battery-powered instrument intended to measure and document alcohol concentrations in human breath at the point-of-care.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DJZ | Devices, Breath Trapping, Alcohol |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K102225 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
1cd475a1-9476-4456-a966-c87a7d2dfe47
September 30, 2022
1
September 22, 2022
September 30, 2022
1
September 22, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
G354CCP044104 | 500 | G354CCP044103 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
G354CCP044100
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined