FDA UDI
In Commercial Distribution
🇺🇸 United States
APHERESIS MACHINE
DI: 04987671040374
·
Model: KANEKA MA-03
·
KANEKA PHARMA AMERICA LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- APHERESIS MACHINE
- Primary DI
- 04987671040374
- Version / Model
- KANEKA MA-03
- Company Name
- KANEKA PHARMA AMERICA LLC
- Labeler DUNS
- 136605362
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-25
- Public Version
- 3
- Public Version Date
- 2018-05-29
- Public Version Status
- Update
- Public Device Record Key
- da239c04-1a04-4389-a543-7e3f31de50b4
Device Description
Indications for FH: The Apheresis Machine KANEKA MA-03 is 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 Apheresis Machine KANEKA MA-03 is 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
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 16405 | Apheresis system | An assembly of electrically-powered devices designed for the extracorporeal separation and removal of a constituent of whole blood (e.g., plasma, platelets, leukocytes) and pathogens, and the return of the remaining constituents to the patient. It typically includes pumps to circulate the blood and uses methods such as membrane filtration, centrifugation, adsorption, or a combination of these to separate the constituent from the blood. The system may be used therapeutically (e.g., to remove immune complexes or low density lipoproteins) or for the harvesting of blood constituents (e.g., for HLA-matched platelets or fresh frozen plasma). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987671040374 | GS1 |
Customer Contacts
- Phone
- 8005263521
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The machine should be installed in the following locations: Ambient temereture should be between 50-95 degrees Fahrenheit and the humidity should be less than 85%
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 95 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- – 85 Percent (%) Relative Humidity