Identity
- Trade Name
- Mui Scientific FDA UDI
- Generic Name
- Gastrointestinal barostat FDA UDI
- Device Name
- 220 V, 8 Channel Compressed Air Electrical Pump FDA UDI
- Model / Reference
- P1PIP48220SS FDA UDI
- Description
- 220 V, 8 Channel Compressed Air Electrical Pump FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00678467504425 FDA UDI
- 510(k) Number
- K122294 FDA UDI
- FDA Product Code
- FFX FDA UDI
- GMDN Term
- Gastrointestinal barostat 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gastrointestinal barostat
Mui Scientific by H & A Mui Enterprises Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Distender II Barostat — G & J Electronics, Inc. · Class II
- Distender II Barostat — G & J Electronics, Inc. · Class II
- EndoFLIP — Covidien LP · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- H & A Mui Enterprises Inc
Sources (1)
- FDA UDI e66c7dd9-16ad-42ad-92ce-6567d566431d 34 fields · synced May 30, 2026