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Hemolung® Catheter Spare Parts Kit 41100

by Alung Technologies, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850046004322 UDI-DI Date21 Feb 2023ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Hemolung® Catheter Spare Parts Kit
Generic Name
Mobile extracorporeal gas exchange system
Model / Reference
41100
Primary DI / UDI-DI
00850046004322
De Novo Number
FDA Product Code
QOH
GMDN Term
Mobile extracorporeal gas exchange system
Device Class
Class II
Regulation Number
870.4150
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Alung Technologies, Inc.

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