Catalog Number

1108

Brand Name

N/A

Version/Model Number

1108

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

-

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

BYG

Product Code Name

MASK, OXYGEN

Public Device Record Key

34cf4702-492b-4189-a46c-dfc4452b129f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 30, 2016

Package DI Number

10607411301190

Quantity per Package

10

Contains DI Package

00607411301193

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-