Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-6221

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

4e53b8c5-c8d0-478a-911a-2c36fa9f0531

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

January 08, 2019

Package DI Number

40612479239867

Quantity per Package

50

Contains DI Package

10612479239859

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case