Duns Number:536137748
Device Description: The FOX MOBILE Inhalation System consists of following components: base unit, charger, Inh The FOX MOBILE Inhalation System consists of following components: base unit, charger, Inhalation set, carry case, instructions for use.
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
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |