LIXELLE N/A
GUDID 04993478010069
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| Primary Device ID | 04993478010069 |
| NIH Device Record Key | e2a2f272-537d-4012-b3dc-30d3f22d0ade |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LIXELLE |
| Version Model Number | S-25 |
| 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 |
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). |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04993478010069 [Unit of Use] |
| GS1 | 14993478010066 [Primary] |
| GS1 | 24993478010063 [Package] Contains: 14993478010066 Package: [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-04 |
| Device Publish Date | 2024-10-25 |
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 |
| 04993478010069 | The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients |
| 04993478010052 | The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients |
| 24993478010049 | 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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