Catalog Number

-

Brand Name

POCKET AIR

Version/Model Number

MBPN00202

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

af8baadb-fdd6-4f9d-8f25-d8d4180f60f9

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

June 08, 2020

Package DI Number

14719874690103

Quantity per Package

100

Contains DI Package

04719874690106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-