← Back to catalogue

Lixelle

FDA UDI

Class Unclassified (US FDA UDI)

by Kaneka Corp.

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-15 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
14993478010059 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
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

Category: Haemoperfusion system absorption column

Lixelle by Kaneka Corp. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemoperfusion system absorption column.

Cleared under the same submission

H130001 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Kaneka Corp.

Sources (1)

  • FDA UDI 46b78a1c-7856-4d70-a3a3-788c91f85f11 37 fields · synced May 30, 2026