Catalog Number

146918

Brand Name

VBMax28e

Version/Model Number

VBMax28E - 146918

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"

-

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

68d13163-d54e-4cbf-828a-f079723c23e4

Public Version Date

July 16, 2018

Public Version Number

1

DI Record Publish Date

June 13, 2018

Package DI Number

00817081021370

Quantity per Package

400

Contains DI Package

00817081021363

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-