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Mui Scientific P4-A-320

by H & A Mui Enterprises 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 Number00678467002105 UDI-DI Date16 Dec 2020ListedStatusListed 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  • Withdrawn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
Mui Scientific
Generic Name
Gastrointestinal barostat
Model / Reference
P4-A-320
Primary DI / UDI-DI
00678467002105
510(k) Number
FDA Product Code
FFX
GMDN Term
Gastrointestinal barostat
Device Class
Class II
Regulation Number
876.1725
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K122294)

Other devices from H & A Mui Enterprises Inc

See all devices from H & A Mui Enterprises Inc →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: 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
  • Lot / Batch Number: No
  • Expiration Date: No