Catalog Number

VM2LBB20

Brand Name

Latex-free Breathing Bag - 2 Liter

Version/Model Number

VM2LBB20

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

e8248cfe-5ec3-4a23-8515-845eeb4c186f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 29, 2016

Package DI Number

30636207315411

Quantity per Package

20

Contains DI Package

00636207315410

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case