Identity
- Trade Name
- FIZE kUO Disposable kit Pediatrics FDA UDI
- Generic Name
- Urine monitoring system FDA UDI
- Model / Reference
- FI-FGUS-KU03-0030 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290019239253 FDA UDI
- FDA Product Code
- EXY FDA UDI
- GMDN Term
- Urine monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
FIZE kUO Disposable kit Pediatrics by Fize Research Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Fize Research Ltd
Sources (1)
- FDA UDI 5122de2b-517e-4b7c-aac5-8792e2074c1d 33 fields · synced May 30, 2026