Catalog Number

-

Brand Name

Typenex Bacterial/Viral Filter

Version/Model Number

RE0301

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

K033008,K033008

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

52311f97-94bb-409b-8b9d-ae2f648e3b56

Public Version Date

April 13, 2022

Public Version Number

1

DI Record Publish Date

April 05, 2022

Package DI Number

10810050854471

Quantity per Package

50

Contains DI Package

00810050854474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case