Catalog Number

-

Brand Name

VENTURI MASK ADULT W/7 DILUTERS , W/7FT TUBING, 6 INCH CORRUGATE TUBE

Version/Model Number

VM-98010

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

-

Product Code

BYF

Product Code Name

Mask, Oxygen, Low Concentration, Venturi

Public Device Record Key

5feecf61-61e1-4da3-8e7f-bc90c1968013

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-