DEVICE: H2H Substitution Filter (00896241002077)
Device Identifier (DI) Information
H2H Substitution Filter
70-6828
Not in Commercial Distribution
NEPHROS, INC.
70-6828
Not in Commercial Distribution
NEPHROS, INC.
H2H Substitution Filter and packaging information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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47334 | Haemodialysis system dialysate pyrogen-filtration set |
A collection of sterile devices designed to be used with a haemodialysis system for on-line filtration of the dialysate to remove bacteria and endotoxins during haemodialysis. This purified (filtered) dialysate is used for the replacement fluid (substitution solution). It includes tubing with an integrated filter(s), and typically connectors (e.g., Luer-lock) and a sampling port. 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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K112314 | 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
225b8689-3a8b-449d-9f69-ad10415b37d7
September 17, 2021
5
September 24, 2016
September 17, 2021
5
September 24, 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 |
---|---|---|---|---|---|
10896241002074 | 5 | 00896241002077 | 2021-09-16 | Not in Commercial Distribution | Carton |
20896241002071 | 20 | 10896241002074 | 2021-09-16 | Not in Commercial Distribution | Box |
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
[?]
No Customer Contact currently defined