Catalog Number

20801-50

Brand Name

VIROBAC II®VIRAL/BACTERIAL FILTER

Version/Model Number

20801-50

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 08, 2021

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

90ad2a1f-346c-4ec0-9b98-caadca466de8

Public Version Date

April 09, 2021

Public Version Number

6

DI Record Publish Date

September 21, 2016

Package DI Number

00612649102313

Quantity per Package

50

Contains DI Package

00612649185590

Package Discontinue Date

April 08, 2021

Package Status

Not in Commercial Distribution

Package Type

-