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sLA Membrane Lung

by Novalung GmbH

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 Number04260058550711 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  • Withdrawn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
Novalung® Surgical Lung Assist (sLA) MembraneLung TM, 8800076
Primary DI / UDI-DI
04260058550711
FDA Product Code
DTZ
GMDN Term
Extracorporeal membrane oxygenator
Device Class
Class II
Regulation Number
870.4350
GUDID distribution status
Not in Commercial Distribution

Other devices from Novalung GmbH

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