FDA UDI
In Commercial Distribution
🇺🇸 United States
SULFLUX
DI: 04537693900639
·
Model: KP-05
·
KANEKA PHARMA AMERICA LLC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SULFLUX
- Primary DI
- 04537693900639
- Version / Model
- KP-05
- Company Name
- KANEKA PHARMA AMERICA LLC
- Labeler DUNS
- 136605362
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-12-17
- Public Version
- 3
- Public Version Date
- 2018-05-30
- Public Version Status
- Update
- Public Device Record Key
- 60c61996-7a3d-4b09-ac1d-15f9dbe94574
Device Description
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).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PBN | Apheresis For Focal Glomerulosclerosis In Pediatric Patients | Unknown | f | |
| MMY | Lipoprotein, Low Density, Removal | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36194 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14537693900636 | GS1 | Outer Carton | 6 | In Commercial Distribution | |
| Primary | 04537693900639 | GS1 |
Customer Contacts
- Phone
- 8005263521
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius