DEVICE: SULFLUX (04537693900639)

Device Identifier (DI) Information

SULFLUX
KP-05
In Commercial Distribution

KANEKA PHARMA AMERICA LLC
04537693900639
GS1

1
136605362 *Terms of Use
Indications for FH: The SULFLUX KP-05 Plasma Separator is one of three disposable device 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 SULFLUX KP-05 Plasma Separator is one of three disposable device 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).
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Apheresis system filter, whole blood A sterile device designed to separate plasma from the cellular components of whole blood during manual/automated apheresis (the separation, collection, and reinfusion of blood) for donation of blood products or apheresis therapy. It typically contains a microporous membrane (usually with pores 0.2 to 0.6 micrometers) or a hollow-fibre column; it may also be intended to filter microorganisms and/or particles. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
PBN Apheresis For Focal Glomerulosclerosis In Pediatric Patients
MMY Lipoprotein, Low Density, Removal
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: 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 and 30 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

60c61996-7a3d-4b09-ac1d-15f9dbe94574
May 30, 2018
3
December 17, 2014
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
14537693900636 6 04537693900639 In Commercial Distribution Outer Carton
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8005263521
info@liposorber.com
CLOSE