Duns Number:355470923
Device Description: Provox Luna ShowerAid is single patient use device intended to be placed into a Provox Lun Provox Luna ShowerAid is single patient use device intended to be placed into a Provox Luna Adhesive while taking a shower to protect the tracheostoma from water.
Catalog Number
8016
Brand Name
Provox Luna ShowerAid
Version/Model Number
8016
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYD
Product Code Name
Condenser, Heat And Moisture (Artificial Nose)
Public Device Record Key
7e82e627-ad64-497e-a443-b1dc43660de5
Public Version Date
July 20, 2022
Public Version Number
1
DI Record Publish Date
July 12, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 119 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 169 |