Catalog Number

-

Brand Name

FILTA-GUARD™ BACTERIAL/VIRAL FILTER

Version/Model Number

1944030

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K911427,K911427

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

9da9da44-0cf1-4288-bd72-d4b73305b3c1

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 06, 2021

Package DI Number

05030267021758

Quantity per Package

40

Contains DI Package

05030267056910

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-