DEVICE: Checkpoint (G354CCP082001)

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Device Record History
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Device Identifier (DI) Information
Checkpoint
CP08
In Commercial Distribution
CCP08200
Alcopro Inc.
G354CCP082001
HIBCC

25
113044739 *Terms of Use
Disposable breath alcohol test
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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
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FDA Product Code

[?]
Product Code Product Code Name
DJZ Devices, Breath Trapping, Alcohol
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K102225 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
8e1f7d80-f65d-4117-81f4-ea5354db7895
September 30, 2022
1
September 22, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
G354CCP082002 50 G354CCP082001 In Commercial Distribution
G354CCP082003 100 G354CCP082002 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: G354CCP082000 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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