Catalog Number

-

Brand Name

Adult Face Tent

Version/Model Number

111-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

21ea8beb-f505-44c1-8f12-51de74851f43

Public Version Date

October 26, 2018

Public Version Number

1

DI Record Publish Date

September 25, 2018

Package DI Number

10709078005753

Quantity per Package

50

Contains DI Package

00709078005756

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-