DEVICE: TQE Plus Endotoxin 30" Filter Flat 222 Head (00868277000433)
Device Identifier (DI) Information
TQE Plus Endotoxin 30" Filter Flat 222 Head
TQE0.005-30P3E
Not in Commercial Distribution
NEPHROS, INC.
TQE0.005-30P3E
Not in Commercial Distribution
NEPHROS, INC.
The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
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? |
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33627 | Peritoneal dialysis system dialysate filter |
A microporous device used to capture contamination particles of the dialysate before its instillation into the peritoneal cavity. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FIP | Subsystem, Water Purification |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K161304 | 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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No Device Sizes |
Device Record Status
93b39d0f-a476-4c3a-8ed4-792be28be137
February 14, 2024
6
December 21, 2017
February 14, 2024
6
December 21, 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 |
---|---|---|---|---|---|
20868277000437 | 15 | 10868277000430 | 2024-02-13 | Not in Commercial Distribution | 15 boxes per carton |
10868277000430 | 1 | 00868277000433 | 2024-02-13 | Not in Commercial Distribution | 1 part per box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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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