DEVICE: Pall-Aquasafe™ Water Filter (05034480313744)
Device Identifier (DI) Information
Pall-Aquasafe™ Water Filter
AQ31F1RA
In Commercial Distribution
AQ31F1RA
Pall International Sàrl
AQ31F1RA
In Commercial Distribution
AQ31F1RA
Pall International Sàrl
0.2 micron Water Filter - Faucet with Permanent Shower Spray (Rose) for 31 day use
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NHV | SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K153434 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Pore Size: 0.2 Micrometer |
Device Record Status
b72aa1fc-d798-47a4-bfcd-c7c7302752f3
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 |
---|---|---|---|---|---|
35034480313745 | 12 | 05034480313744 | In Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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