Catalog Number

1107-0

Brand Name

N/A

Version/Model Number

1107-0

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

17b00704-ff59-4438-bb25-2a6019a333f0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 30, 2016

Package DI Number

20607411800874

Quantity per Package

50

Contains DI Package

10607411800877

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-