Catalog Number

-

Brand Name

Aero/Vent Plus

Version/Model Number

MN5045

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

BSJ

Product Code Name

Mask, Gas, Anesthetic

Public Device Record Key

f9642eb7-c265-4e2b-9eca-99af81e15752

Public Version Date

November 19, 2020

Public Version Number

4

DI Record Publish Date

June 09, 2017

Package DI Number

00857863007543

Quantity per Package

20

Contains DI Package

00857863007468

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton