Catalog Number

AAB1520

Brand Name

AlcoBreath Tube

Version/Model Number

ABT15

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

DJZ

Product Code Name

Devices, Breath Trapping, Alcohol

Public Device Record Key

c0328266-d9df-49b5-8df8-6103f291ba55

Public Version Date

September 30, 2022

Public Version Number

1

DI Record Publish Date

September 22, 2022

Package DI Number

G354AAB15202

Quantity per Package

100

Contains DI Package

G354AAB15201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-