Catalog Number

4055-10

Brand Name

Adsafe™

Version/Model Number

4055-10

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"

-

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

3a1153f2-b051-4ffc-bc4c-f0a2c6762155

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

00634782554996

Quantity per Package

10

Contains DI Package

00634782055219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master case