Catalog Number

-

Brand Name

Filter

Version/Model Number

10-55376

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

K954490,K954490

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

8061462e-9a5a-45a9-a72d-e242ea799bc8

Public Version Date

September 22, 2020

Public Version Number

5

DI Record Publish Date

April 01, 2016

Package DI Number

30641043553767

Quantity per Package

20

Contains DI Package

10641043553763

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-