Identity
- Trade Name
- Lixelle FDA UDI
- Generic Name
- Haemoperfusion system absorption column FDA UDI
- Device Name
- The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA). FDA UDI
- Model / Reference
- S-25 FDA UDI
- Description
- The Lixelle(r) beta 2-microglobulin apheresis column is indicated for the treatment of patients with clinically-diagnosed dialysis-related amyloidosis (DRA). FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 14993478020225 FDA UDI
- PMA Number
- H130001 FDA UDI
- FDA Product Code
- PDI FDA UDI
- GMDN Term
- Haemoperfusion system absorption column FDA UDI
Classification
- Device Class
- Unclassified FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Lixelle by Kaneka Corp. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
H130001 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class Unclassified | Pending data |
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Manufacturer
- Manufacturer
- Kaneka Corp.
Sources (1)
- FDA UDI e80bdbdd-013c-4256-aac0-1b477a99aecd 38 fields · synced May 30, 2026