DEVICE: APHERESIS MACHINE (04987671040374)

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Device Identifier (DI) Information

APHERESIS MACHINE
KANEKA MA-03

KANEKA PHARMA AMERICA LLC
04987671040374
GS1
1
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 pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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

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Product Code Product Code Name
PBN Apheresis For Focal Glomerulosclerosis In Pediatric Patients
MMY Lipoprotein, Low Density, Removal
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Sterilization

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

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 25, 2014

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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8005263521
info@liposorber.com
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