Catalog Number

-

Brand Name

POCKET AIR

Version/Model Number

MBPN00203

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)

-

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

b9259c38-4ac9-4944-a93d-6576e305161b

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

June 03, 2020

Package DI Number

14719874690073

Quantity per Package

200

Contains DI Package

04719874690076

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-