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Mui Scientific

FDA UDI

Class II (US FDA UDI)

by H & A Mui Enterprises Inc

Identity

Trade Name
Mui Scientific FDA UDI
Generic Name
Manometric gastrointestinal motility analysis system FDA UDI
Device Name
24 Channel Portable Compressed Air Manometric Pump FDA UDI
Model / Reference
P3-PIP-6-24SS FDA UDI
Description
24 Channel Portable Compressed Air Manometric Pump FDA UDI

Identifiers

Primary DI / UDI-DI
00678467003430 FDA UDI
510(k) Number
K122294 FDA UDI
FDA Product Code
FFX FDA UDI
GMDN Term
Manometric gastrointestinal motility analysis system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1725 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Manometric gastrointestinal motility analysis system

Mui Scientific by H & A Mui Enterprises Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manometric gastrointestinal motility analysis system.

Cleared under the same submission

K122294 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
H & A Mui Enterprises Inc

Sources (1)

  • FDA UDI 463eb436-a2ab-4b95-8bc2-d73dd32e382a 35 fields · synced May 30, 2026