Catalog Number

08CD0010

Brand Name

FOX MOBILE

Version/Model Number

FOX MOBILE Inhalation System (US)

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

-

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

K142059,K142059

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

727bbe49-6ab7-4c92-b2f7-5c6cd79706a7

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

May 05, 2017

Package DI Number

05056143200048

Quantity per Package

4

Contains DI Package

05056143200031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-