DEVICE: APHERESIS MACHINE (04987671040374)
Device Identifier (DI) Information
APHERESIS MACHINE
KANEKA MA-03
In Commercial Distribution
KANEKA PHARMA AMERICA LLC
KANEKA MA-03
In Commercial Distribution
KANEKA PHARMA AMERICA LLC
Indications for FH:
The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma.
Indications for FSGS:
The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
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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16405 | Apheresis system |
An assembly of electrically-powered devices designed for the extracorporeal separation and removal of a constituent of whole blood (e.g., plasma, platelets, leukocytes) and pathogens, and the return of the remaining constituents to the patient. It typically includes pumps to circulate the blood and uses methods such as membrane filtration, centrifugation, adsorption, or a combination of these to separate the constituent from the blood. The system may be used therapeutically (e.g., to remove immune complexes or low density lipoproteins) or for the harvesting of blood constituents (e.g., for HLA-matched platelets or fresh frozen plasma).
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FDA Product Code
[?]Product Code | Product Code Name |
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PBN | Apheresis For Focal Glomerulosclerosis In Pediatric Patients |
MMY | Lipoprotein, Low Density, Removal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: The machine should be installed in the following locations: Ambient temereture should be between 50-95 degrees Fahrenheit and the humidity should be less than 85% |
Storage Environment Temperature: between 50 and 95 Degrees Fahrenheit |
Storage Environment Humidity: less than 85 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
da239c04-1a04-4389-a543-7e3f31de50b4
May 29, 2018
3
September 25, 2014
May 29, 2018
3
September 25, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
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
[?]
8005263521
info@liposorber.com
info@liposorber.com