Catalog Number

-

Brand Name

SOBERLINK

Version/Model Number

SOBERLINK LTE - 06

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160613

Product Code

DJZ

Product Code Name

Devices, Breath Trapping, Alcohol

Public Device Record Key

33b729dc-432b-4580-8262-ea5b9042eca3

Public Version Date

December 16, 2021

Public Version Number

1

DI Record Publish Date

December 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-