| Primary Device ID | 04987671040374 |
| NIH Device Record Key | da239c04-1a04-4389-a543-7e3f31de50b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APHERESIS MACHINE |
| Version Model Number | KANEKA MA-03 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8005263521 |
| info@liposorber.com |
| Special Storage Condition, Specify | Between 0 and 0 *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% |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987671040374 [Primary] |
| PBN | Apheresis For Focal Glomerulosclerosis In Pediatric Patients |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-29 |
| Device Publish Date | 2014-09-25 |
| 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 | 2018-05-30 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 | 2018-05-29Indications for FH: The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for us |
| 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 |