Duns Number:536137748
Device Description: The FOX MOBILE Inhalation Set (US) is part of the FOX MOBILE Inhalation System (US) and co The FOX MOBILE Inhalation Set (US) is part of the FOX MOBILE Inhalation System (US) and consists of following components: Nebulizer head, nebulizer mouthpiece and instructions for use (for FOX MOBILE Inhalation Set).
Catalog Number
08CD0025
Brand Name
FOX MOBILE
Version/Model Number
FOX MOBILE Inhalation Set (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,K142059
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
8eac8540-8f36-4590-92e7-d5b0500c6f43
Public Version Date
June 10, 2022
Public Version Number
9
DI Record Publish Date
May 05, 2017
Package DI Number
05056143200062
Quantity per Package
48
Contains DI Package
05056143200055
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 |