Checkpoint - Disposable breath alcohol test - Alcopro Inc.

Duns Number:113044739

Device Description: Disposable breath alcohol test

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More Product Details

Catalog Number

CCP02410

Brand Name

Checkpoint

Version/Model Number

CP02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K102225,K102225,K102225

Product Code Details

Product Code

DJZ

Product Code Name

Devices, Breath Trapping, Alcohol

Device Record Status

Public Device Record Key

359dd84a-7719-4d2e-b808-3481f5673923

Public Version Date

September 30, 2022

Public Version Number

1

DI Record Publish Date

September 22, 2022

Additional Identifiers

Package DI Number

G354CCP024104

Quantity per Package

500

Contains DI Package

G354CCP024103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ALCOPRO INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2