Catalog Number

-

Brand Name

POCKET AIR

Version/Model Number

MBPN002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

7d346669-e679-43f6-bb1b-ef8e4bf3cf04

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 31, 2020

Package DI Number

14719874690066

Quantity per Package

24

Contains DI Package

04719874690069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-