Catalog Number

20801

Brand Name

VIROBAC II®VIRAL/BACTERIAL FILTER

Version/Model Number

20801

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

K880681,K880681

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

3d0d1b77-f595-4388-9880-154a2e5ab52b

Public Version Date

September 22, 2020

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

00612649102290

Quantity per Package

40

Contains DI Package

00612649185583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-