Home GUDID 24993478010117 LIPOSORBER
Primary DI 24993478010117
Brand LIPOSORBER
Company KANEKA CORPORATION
Model LA-15
Catalog number N/A
Device description Indications for FH: The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely r
Published 2014-09-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name PBN Apheresis For Focal Glomerulosclerosis In Pediatric Patients
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PBN Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients Unknown f
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 24993478010117 Package GS1 6 In Commercial Distribution 14993478010110 Primary GS1 0 04993478010113 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 24993478010117 24993478010117 14993478010110 14993478010110 04993478010113 04993478010113 4993478010113
GMDN Terms# Term, Definition table Term Definition Haemoperfusion system absorption column A sterile container that is a component of a haemoperfusion system used for the removal of toxins from a patient's blood, and that holds materials (e.g., activated carbon or resins) which absorb (adsorb) a specific toxin or range of toxins. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 In transporting and storing, handle with care and store in a clean and secure area at room temperature (5-30°C), avoiding exposure to direct sunlight, high humidity or excessive vibration. Storage Environment Temperature 5 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 690535406 Device count 2 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# 
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