Identity
- Trade Name
- Mui Scientific FDA UDI
- Generic Name
- Gastrointestinal motility manometric catheter, non-electronic FDA UDI
- Device Name
- Clear TPE Unbeaded Balloon 150mL FDA UDI
- Model / Reference
- CBE5T FDA UDI
- Description
- Clear TPE Unbeaded Balloon 150mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00678467003775 FDA UDI
- 510(k) Number
- K823701 FDA UDI
- FDA Product Code
- FFX FDA UDI
- GMDN Term
- Gastrointestinal motility manometric catheter, non-electronic 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 motility manometric catheter, non-electronic
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 Gastrointestinal motility manometric catheter, non-electronic.
- Mediplus — Mediplus , Ltd. · Class II
- Latitude Catheter — Unisensor AG · Class II
- Mediplus — Mediplus , Ltd. · Class II
- Mediplus — Mediplus , Ltd. · Class II
- Mui Scientific — H & A Mui Enterprises Inc · Class II
- Mui Scientific — H & A Mui Enterprises Inc · Class II
- Mui Scientific — H & A Mui Enterprises Inc · Class II
- Mui Scientific — H & A Mui Enterprises Inc · Class II
Cleared under the same submission
K823701 also covers:
- Mui Scientific — H & A Mui Enterprises Inc
- Mui Scientific — H & A Mui Enterprises Inc
- Mui Scientific — H & A Mui Enterprises Inc
- Mui Scientific — H & A Mui Enterprises Inc
- Mui Scientific — H & A Mui Enterprises Inc
- Mui Scientific — H & A Mui Enterprises Inc
- Mui Scientific — H & A Mui Enterprises Inc
- Mui Scientific — H & A Mui Enterprises Inc
- Mui Scientific — H & A Mui Enterprises Inc
- Mui Scientific — H & A Mui Enterprises Inc
- Mui Scientific — H & A Mui Enterprises Inc
- Mui Scientific — H & A Mui Enterprises Inc
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- H & A Mui Enterprises Inc
Sources (1)
- FDA UDI bfa87880-f2fb-4b7d-b0da-08390a59acb6 35 fields · synced Jun 8, 2026