Identity
- Trade Name
- Clarity RMS Console FDA UDI
- Generic Name
- Urine monitoring system monitor FDA UDI
- Model / Reference
- ASY00015 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016022025 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
No
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
MR Unsafe FDA UDI
Category: Urine monitoring system monitor
Clarity RMS Console by RenalSense Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine monitoring system monitor.
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · 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 |
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Manufacturer
- Manufacturer
- RenalSense Ltd.
Sources (1)
- FDA UDI cc1c5b8e-8bbb-4108-9dac-5f22cc13fd2c 32 fields · synced May 30, 2026