Identity
- Trade Name
- Pathway FDA UDI
- Generic Name
- Urine monitoring system monitor FDA UDI
- Device Name
- Pathway® DUO for Pediatric Voiding Dysfunction FDA UDI
- Model / Reference
- PDUO FDA UDI
- Description
- Pathway® DUO for Pediatric Voiding Dysfunction FDA UDI
Identifiers
- Catalog Number
- PDUO FDA UDI
- Primary DI / UDI-DI
- 00852423006035 FDA UDI
- FDA Product Code
- EXY FDA UDI
- GMDN Term
- Urine monitoring system monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1800 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Urine monitoring systemUrine flowmeter, reusableUrine monitoring system monitorUrine monitoring system sensor
Pathway by Prometheus Group Of New Hampshire Limited, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine monitoring system monitor.
- Clarity RMS Console — RenalSense Ltd. · 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
- Prometheus Group Of New Hampshire Limited, The
Sources (1)
- FDA UDI 4e1b0887-5b97-41ed-900b-31787b868229 35 fields · synced May 30, 2026