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MC 300 Reusable Nebulizer MC300

by Monaghan Medical Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00604351673106 UDI-DI Date26 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MC 300 Reusable Nebulizer
Generic Name
Therapeutic agent nebulizer, benchtop
Model / Reference
MC300
Primary DI / UDI-DI
00604351673106
510(k) Number
FDA Product Code
CAF
GMDN Term
Therapeutic agent nebulizer, benchtop
Device Class
Class II
Regulation Number
868.5630
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K173367)

Other devices from Monaghan Medical Corp.

See all devices from Monaghan Medical Corp. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

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