Identity
- Trade Name
- Mediplus FDA UDI
- Generic Name
- Gastrointestinal motility manometric catheter, non-electronic FDA UDI
- Device Name
- 8 channel antroduodenal catheter, 3.9mm FDA UDI
- Model / Reference
- 2273 FDA UDI
- Description
- 8 channel antroduodenal catheter, 3.9mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055140700520 FDA UDI
- 510(k) Number
- K013704 FDA UDI
- FDA Product Code
- KLA 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 200.0 Centimeter FDA UDIOuter Diameter — 3.9 Millimeter FDA UDI
Category: Gastrointestinal motility manometric catheter, non-electronic
Mediplus by Mediplus , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K013704 also covers:
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
- Mediplus , Ltd.
Sources (1)
- FDA UDI e2d89531-a3a7-4ea9-86c8-c490f678103b 36 fields · synced May 30, 2026