SULFLUX

GUDID 14537693900636

Indications for FH: The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® L

KANEKA PHARMA AMERICA LLC

Apheresis system filter, whole blood

• Primary Device ID: 14537693900636
• NIH Device Record Key: 60c61996-7a3d-4b09-ac1d-15f9dbe94574
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SULFLUX
• Version Model Number: KP-05
• Company DUNS: 136605362
• Company Name: KANEKA PHARMA AMERICA LLC
• Device Count: 1
• 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: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *In transporting and storing the Plasma Separator, handle with care. Store in a clean and secure area, avoiding exposure to direct sunlight, high humidity or excessive vibration.
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04537693900639 [Primary]
GS1	14537693900636 [Package]; Contains: 04537693900639; Package: Outer Carton [6 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2018-05-30
• Device Publish Date: 2014-12-17

Devices Manufactured by KANEKA PHARMA AMERICA LLC

• 18855036020688 - TUBING SYSTEM FOR PLASMAPHERESIS: 2018-09-21 Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBE
• 14537693900636 - SULFLUX: 2018-05-30Indications for FH: The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® L
• 14537693900636 - SULFLUX: 2018-05-30 Indications for FH: The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 Sy
• 18855036012850 - TUBING SYSTEM FOR PLASMAPHERESIS: 2018-05-29 Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBE
• 04987671040374 - APHERESIS MACHINE: 2018-05-29 Indications for FH: The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 Sy