DEVICE: P1R Plasma Treatment Set (04052682003721)
Device Identifier (DI) Information
P1R Plasma Treatment Set
9400414
In Commercial Distribution
9400414
Fresenius Kabi AG
9400414
In Commercial Distribution
9400414
Fresenius Kabi AG
Therapeutic Plasma Treatment (e.g. LDL-apheresis)
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? |
---|---|---|---|---|
47572 | Apheresis system tubing set |
A collection of sterile, flexible, plastic tube segments and associated items (e.g., connectors, line clamp, drip chamber) intended to be used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to the patient. It creates a closed-circuit for the extracorporeal removal of a constituent of whole blood (e.g., leukocytes, plasma). The channeling of apheresis solutions for the priming, regeneration, preservation of columns before or after an apheresis procedure may also be through the tubing set. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K961706 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 5 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
1c085a0e-f1fe-4721-b0d4-8223ecfbc3de
September 03, 2018
4
September 16, 2016
September 03, 2018
4
September 16, 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 |
---|---|---|---|---|---|
04052682003738 | 5 | 04052682003721 | In Commercial Distribution |
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
[?]
+31591355864
wilma.hilhorst@fresenius-kabi.com
wilma.hilhorst@fresenius-kabi.com