Lixelle N/A
GUDID 24993478020239
The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA).
KANEKA CORPORATION
Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column Haemoperfusion system absorption column| Primary Device ID | 24993478020239 |
| NIH Device Record Key | d53474a0-93e2-4f42-b76f-8f285eb61d57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lixelle |
| Version Model Number | S-35 |
| Catalog Number | N/A |
| Company DUNS | 690535406 |
| Company Name | KANEKA CORPORATION |
| Device Count | 6 |
| 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 | true |
| 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 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com | |
| Phone | 8005263521 |
| info@liposorber.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight, high humidity, excessive vibration and freezing conditions. Do not drop the Lixelle® column or strike it with a hard instrument (e.g., forceps). |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04993478010045 [Unit of Use] |
| GS1 | 04993478020235 [Unit of Use] |
| GS1 | 14993478020232 [Primary] |
| GS1 | 24993478020239 [Package] Contains: 14993478020232 Package: Carrier Box [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- H130001
FDA Product Code
| PDI | Beta 2-Microglobulin Apheresis Column |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-25 |
| Device Publish Date | 2015-05-01 |
On-Brand Devices [Lixelle ]
| 24993478020239 | The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients |
| 24993478020222 | The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients |
| 14993478020218 | The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients |
Trademark Results [Lixelle]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIXELLE 88096883 5860368 Live/Registered |
KANEKA CORPORATION 2018-08-29 |
 LIXELLE 79189550 5139581 Live/Registered |
Kaneka Corporation 2016-04-04 |
 LIXELLE 77118159 3659738 Live/Registered |
KANEKA CORPORATION 2007-02-28 |
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