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Elisio™-Hx Elisio™-21HX

by Nipro Medical Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00383790011815 UDI-DI Date3 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Elisio™-Hx
Generic Name
Hollow-fibre haemodialysis dialyser, single-use
Model / Ref / Catalog
ELISIO™-21HX, DD+ELISIO-21HX
Primary DI / UDI-DI
00383790011815
FDA Product Code
QAX
GMDN Term
Hollow-fibre haemodialysis dialyser, single-use
Device Class
Class II
Regulation Number
876.5862
GUDID distribution status
In Commercial Distribution
Size
Area/Surface Area — 2.1 Square meter

Other devices from Nipro Medical Corporation

See all devices from Nipro Medical Corporation →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No