Catalog Number

29002

Brand Name

GIBECK

Version/Model Number

IPN044134

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K112958,K112958,K112958

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

1341bc15-c559-4eff-b938-9e5a7b965490

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

44026704400797

Quantity per Package

4

Contains DI Package

24026704400793

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case