Catalog Number

28062

Brand Name

GIBECK

Version/Model Number

IPN044104

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

K954828,K954828,K954828

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

8c411d08-a4bf-4026-9e10-7ee04f5d8957

Public Version Date

September 22, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

24026704348125

Quantity per Package

25

Contains DI Package

04026704348121

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box