Catalog Number

4056OR-2

Brand Name

Adsafe

Version/Model Number

4056OR-2

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BYG

Product Code Name

Mask, Oxygen

Public Device Record Key

0638d537-0a66-492e-9030-811dad0ef068

Public Version Date

September 03, 2018

Public Version Number

1

DI Record Publish Date

August 03, 2018

Package DI Number

00634782595425

Quantity per Package

10

Contains DI Package

00634782895426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master