Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-6232

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

K922492,K922492

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

93be0c60-6ed4-43d4-94b5-af86b82fc60c

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

January 08, 2019

Package DI Number

40612479239881

Quantity per Package

25

Contains DI Package

10612479239873

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case