LIPOSORBER N/A

GUDID 24993478010117

Indications for FH: The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely r

KANEKA CORPORATION

Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column

• Primary Device ID: 24993478010117
• NIH Device Record Key: 097fa2bd-0bf9-4ac6-bf30-45a06efc9fb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIPOSORBER
• Version Model Number: LA-15
• Catalog Number: N/A
• Company DUNS: 690535406
• Company Name: KANEKA CORPORATION
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com
• Phone: 8005263521
• Email: info@liposorber.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 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: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04993478010113 [Unit of Use]
GS1	14993478010110 [Primary]
GS1	24993478010117 [Package]; Contains: 14993478010110; Package: Carrier Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• H120005

FDA Product Code

• PBN: Apheresis For Focal Glomerulosclerosis In Pediatric Patients

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-26

Devices Manufactured by KANEKA CORPORATION

• 04540778176485 - i-ED COIL: 2023-08-04 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
• 04540778176423 - i-ED COIL: 2022-06-07 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
• 04540778177253 - i-ED COIL: 2022-06-07 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
• 04540778177543 - i-ED COIL: 2022-06-01 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
• 04540778177550 - i-ED COIL: 2022-06-01 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
• 04540778177604 - i-ED COIL: 2022-06-01 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
• 04540778177611 - i-ED COIL: 2022-06-01 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
• 04540778176430 - i-ED COIL: 2020-07-08 The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.