Skip to content

Lixelle S-15

by Kaneka Corp. 2 variants

Lixelle S-15 is a device classified as Unclassified made by Kaneka Corp., listed under FDA HDE H130001 and listed in FDA GUDID since 25 Oct 2024 (UDI-DI 14993478010059), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

HDE

Valid until

No date given

No validity date on record

FDA recalls

None found

in data synced 23 Oct 2026

Documents

HDE H130001

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number14993478010059 UDI-DI Date25 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA HDE from GUDID NumberH130001 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA HDE H130001 Active
  • FDA GUDID UDI-DI 14993478010059 listed 25 Oct 2024 Listed

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA HDE Active

Specification

GUDID

Trade name
Lixelle
Generic name
Haemoperfusion system absorption column
Model / Ref / Catalog
S-15
Primary DI / UDI-DI
14993478010059
PMA number
FDA product code
PDI
GMDN term
Haemoperfusion system absorption column
Device class
Unclassified
GUDID distribution status
In Commercial Distribution

Related devices

Category: Haemoperfusion system absorption column

Cleared under the same submission (H130001)

Similar devices

Also classified as Haemoperfusion system absorption column.

Other devices from Kaneka Corp.

See all devices from Kaneka Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (9, all answered No)