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mcompass ARM and BIofeedback System
FDA UDIClass II (US FDA UDI)
by Medspira Llc
Identity
- Trade Name
- mcompass ARM and BIofeedback System FDA UDI
- Generic Name
- Manometric gastrointestinal motility analysis system FDA UDI
- Device Name
- Medspira Anorectal Manometry and Biofeedback System FDA UDI
- Model / Reference
- RMD-003 FDA UDI
- Description
- Medspira Anorectal Manometry and Biofeedback System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851607003273 FDA UDI
- 510(k) Number
- K143031 FDA UDI
- FDA Product Code
- KLA FDA UDIHCC FDA UDI
- GMDN Term
- Manometric gastrointestinal motility analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 FDA UDI882.5050 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manometric gastrointestinal motility analysis system
mcompass ARM and BIofeedback System by Medspira Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143031 also covers:
- Medspira mcompass Anorectal Manometry Dock for Tablet PC, w/Power Supply — MEDSPIRA LLC
- Medspira mcompass Anorectal Manometry Tablet PC, w Dock, w Power Cord — MEDSPIRA LLC
- Single Patient Kit, mcompass, Anorectal Manometry 2-channel — MEDSPIRA LLC
- Single Patient Kit, mcompass, Anorectal Manometry 5-channel — MEDSPIRA LLC
- Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite — MEDSPIRA LLC
- mcompass Anorectal Manometry System — MEDSPIRA LLC
- mcompass Biofeedback 2-Channel Catheter — MEDSPIRA LLC
- mcompass Biofeedback Manometry System — MEDSPIRA LLC
- mcompass Extension Tube Set — MEDSPIRA LLC
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
- Medspira Llc
Sources (1)
- FDA UDI 62adbaaa-1b1e-4b79-8239-aa9c1cc9b0b7 35 fields · synced May 30, 2026