Catalog Number

-

Brand Name

Adult Elongated Medium Concentration Mask, 8'

Version/Model Number

3102-E

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

BYG

Product Code Name

Mask, Oxygen

Public Device Record Key

de049f09-3b09-4b0d-b361-77abbe3dc09c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 14, 2017

Package DI Number

10709078003179

Quantity per Package

50

Contains DI Package

00709078003172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-