Catalog Number

156607

Brand Name

VBMax36

Version/Model Number

VBMax36 - 156607

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

K000654,K000654

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

9f32b60c-d43b-453e-b30a-9cbe8d61f987

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 26, 2017

Package DI Number

00817081021073

Quantity per Package

100

Contains DI Package

00817081021066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-