DEVICE: Pall-Aquasafe™ Water Filter (05034480313553)
Device Identifier (DI) Information
Pall-Aquasafe™ Water Filter
AQF4A
In Commercial Distribution
AQF4A
Pall International Sàrl
AQF4A
In Commercial Distribution
AQF4A
Pall International Sàrl
Disposable Shower Head Filter
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58088 | Microbial water purification filter, non-sterilizable |
A sterile device designed to remove bacteria and other suspended particles from flowing water by creating a mechanical barrier to elements larger than 0.2 micrometres. It typically consists of a plastic housing with a connector to the water source [e.g., a tap (faucet)] and a 0.2 micrometre filtering membrane [e.g., made of nylon, polyvinylidene fluoride (PVDF), or polyethersulfone (PES)]; a prefiltration of the water to remove larger particles is typically recommended. It is typically used for hygienic and surgical hand washing, wound irrigation, and/or rinsing of medical devices. This is a disposable, non-sterilizable device which may serve multiple patients before being discarded.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NHV | SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K153434 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Pore Size: 0.2 Micrometer |
Device Record Status
7bdc22b1-d3d5-41cc-8740-f204b908703a
July 06, 2018
3
July 20, 2016
July 06, 2018
3
July 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
35034480313554 | 12 | 05034480313553 | In Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)645-6578
5164843600
QAMedical@pall.com
QAMedical@pall.com