Skip to content

Bionix Development Corporation Dg-912

by M&H Medical Holdings, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number08599110040072 UDI-DI Date26 Oct 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Bionix Development Corporation
Generic Name
Ultrasonic cough stimulation system
Model / Ref / Catalog
DG-912, 912
Primary DI / UDI-DI
08599110040072
510(k) Number
FDA Product Code
KNT
GMDN Term
Ultrasonic cough stimulation system
Device Class
Class II
Regulation Number
876.5980
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K905164)

Show all (10)

Properties

  • Single Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: 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