Catalog Number

146300

Brand Name

VBMax

Version/Model Number

VBMax30E - 146300

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,K000654

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

4c8cfa19-f070-4af8-b896-63b912aa40a5

Public Version Date

August 14, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

00817081020175

Quantity per Package

50

Contains DI Package

00817081020168

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Individually Bagged