Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-D963

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

00cc0a56-a9ce-4b1b-95b5-4a57bddb5b5a

Public Version Date

September 22, 2020

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

40612479210705

Quantity per Package

20

Contains DI Package

10612479210698

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case