Duns Number:001804074
Device Description: Fix mount and hand held shower head convenience kit, brushed nickel
Catalog Number
XPA-139E/769ME
Brand Name
Waterpik PowerPulse 2in1 Shower System with One Touch
Version/Model Number
XPA-139E/769ME
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYG
Product Code Name
Massager, Therapeutic, Manual
Public Device Record Key
2f14bb3f-135c-492f-b880-96be5eea0a6f
Public Version Date
May 03, 2022
Public Version Number
2
DI Record Publish Date
June 24, 2021
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 | 293 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 56 |