Catalog Number

146516

Brand Name

VBMax35E

Version/Model Number

VBMax35E - 146516

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

505203f3-c9d2-4d33-96a5-349b71f84d60

Public Version Date

August 26, 2020

Public Version Number

1

DI Record Publish Date

August 18, 2020

Package DI Number

00817081026795

Quantity per Package

100

Contains DI Package

00817081026788

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-