DEVICE: EndoPur Endotoxin 10" Filter Fin (00866318000367)
Device Identifier (DI) Information
EndoPur Endotoxin 10" Filter Fin
70-0110F
Not in Commercial Distribution
NEPHROS, INC.
70-0110F
Not in Commercial Distribution
NEPHROS, INC.
Intended Use: The EndoPur Endotoxin 10” Filter Fin is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
Indications for Use: The EndoPur Endotoxin 10” Filter Fin is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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 |
---|---|
FIP | Subsystem, Water Purification |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K110285 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
23021270-501f-4125-a6a0-b408e783d03a
November 11, 2024
5
September 29, 2017
November 11, 2024
5
September 29, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20866318000361 | 30 | 10866318000364 | 2017-12-18 | Not in Commercial Distribution | Carton Box |
10866318000364 | 1 | 00866318000367 | 2017-12-18 | Not in Commercial Distribution | Filter Box |
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
[?]
No Customer Contact currently defined