Identity
- Trade Name
- Diversatek Healthcare FDA UDI
- Generic Name
- Manometric gastrointestinal motility analysis system FDA UDI
- Device Name
- HRiM SD High Resolution Impedance Manometry Probe Kit FDA UDI
- Model / Reference
- HRIMSD-KIT FDA UDI
- Description
- HRiM SD High Resolution Impedance Manometry Probe Kit FDA UDI
Identifiers
- Catalog Number
- HRIMSD-KIT FDA UDI
- Primary DI / UDI-DI
- 00816734023457 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manometric gastrointestinal motility analysis system
Diversatek Healthcare by Diversatek Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manometric gastrointestinal motility analysis system.
- Endoflip — Covidien LP · Class II
- Manoscan — Given Imaging , Ltd. · Class II
- Mui Scientific — H & A Mui Enterprises Inc · Class II
- Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite — MEDSPIRA LLC · Class II
- Endoflip — Covidien LP · Class II
- ManoScan — Given Imaging , Ltd. · Class II
- ManoView — Given Imaging , Ltd. · Class II
- Endoflip — Covidien LP · Class II
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
- Diversatek Healthcare
Sources (1)
- FDA UDI b7c79a25-0ff6-4920-8d76-03be73ed0825 35 fields · synced Jun 8, 2026