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NATROX® Oxygen Wound Therapy Oxygen Delivery System

by Inotec Amd, Ltd. 5 variants

Listed FDA GUDID listing, no authorization on record

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 Number05060371000356 UDI-DI Date12 Dec 2025ListedStatusListed GUDID: 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  • Withdrawn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
NATROX® Oxygen Wound Therapy
Generic Name
Wound therapy oxygenator, single-use
Model / Ref / Catalog
Oxygen Delivery System, NA055-10-01
Primary DI / UDI-DI
05060371000356
510(k) Number
FDA Product Code
KPJ
GMDN Term
Wound therapy oxygenator, single-use
Device Class
Class II
Regulation Number
878.5650
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K112634)

Other devices from Inotec Amd, Ltd.

See all devices from Inotec Amd, Ltd. →

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