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hilite

by Medos Medizintechnik Aktiengesellschaft 7 variants

Listed FDA GUDID listing, not in commercial distribution

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 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04250358151657 UDI-DI Date30 Sep 2015ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Extracorporeal membrane oxygenator
Model / Ref / Catalog
hilite 800 LT hollow fiber oxygenator for neonates and infants, model 0L01, MW 6208 0L01
Primary DI / UDI-DI
04250358151657
FDA Product Code
DTZ
GMDN Term
Extracorporeal membrane oxygenator
Device Class
Class II
Regulation Number
870.4350
GUDID distribution status
Not in Commercial Distribution

Properties

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

Other properties (9)

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