Duns Number:485050483
Device Description: 0.2 micron Water Filter - Faucet with Permanent Shower Spray (Rose) for 31 day use
Catalog Number
AQ31F1RA
Brand Name
Pall-Aquasafe™ Water Filter
Version/Model Number
AQ31F1RA
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
b72aa1fc-d798-47a4-bfcd-c7c7302752f3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 20, 2016
Package DI Number
35034480313745
Quantity per Package
12
Contains DI Package
05034480313744
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 |