Duns Number:485050483
Device Description: Detachable Shower Rose - For use with Pall-Aquasafe Water Filter - Faucet (AQ31F1SA) for 3 Detachable Shower Rose - For use with Pall-Aquasafe Water Filter - Faucet (AQ31F1SA) for 31 day use
Catalog Number
AQROSEA
Brand Name
Pall-Aquasafe™ Detachable Shower Rose
Version/Model Number
AQROSEA
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"
Yes
For Single-Use
Yes
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
K153434,K153434
Product Code
NHV
Product Code Name
SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE
Public Device Record Key
38990289-a420-47ea-98cd-0a03190ca1ac
Public Version Date
November 06, 2020
Public Version Number
4
DI Record Publish Date
July 20, 2016
Package DI Number
35034480314803
Quantity per Package
25
Contains DI Package
05034480314802
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |