Catalog Number

VMFLEX

Brand Name

Expandable 15 mm x 5 inch Flex Tube

Version/Model Number

VMFLEX

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

K013093,K013093

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

651e47cf-ad9d-40cc-8bfb-061c6066bbb3

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

June 29, 2016

Package DI Number

30636207315459

Quantity per Package

100

Contains DI Package

00636207315458

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case