DEVICE: Nipro Ultrafilter (00383790008860)

Device Identifier (DI) Information

Nipro Ultrafilter
CF+609N
In Commercial Distribution

NIPRO MEDICAL CORPORATION
00383790008860
GS1

1
797372554 *Terms of Use
Filter for clean dialysate and water
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
47739 Haemodialysis system dialysate pyrogen filter
A sterile device designed to be used with a haemodialysis system for filtration of dialysate during haemodialysis to remove bacteria and endotoxins and produce purified dialysate for the procedure. It may perform secondary safety filtering to prepare on-line substitution solution that can be infused into the patient to compensate for loss of fluid volume resulting from haemodialysis. It typically consists of a plastic housing, containing a hollow fibre membrane, with appropriate connectors at either end. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

de56023a-4683-49a4-82b4-6be52889bbdc
July 27, 2020
1
July 17, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
40383790008868 12 00383790008860 In Commercial Distribution case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
908-393-7030
info@nipromed.com
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