FDA UDI
In Commercial Distribution
🇺🇸 United States
FIZE kUO Console
DI: 07290019239031
·
Model: 5G2
·
FIZE RESEARCH LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- FIZE kUO Console
- Primary DI
- 07290019239031
- Version / Model
- 5G2
- Catalog Number
- FI-FG00-KU00-0006
- Company Name
- FIZE RESEARCH LTD
- Labeler DUNS
- 649273943
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-29
- Public Version
- 1
- Public Version Date
- 2025-05-07
- Public Version Status
- New
- Public Device Record Key
- e907d61b-f36d-44a3-9c64-579d49c7c454
Device Description
FIZE kUO Console 5G catalog number: FI-FG00-KU00-0006 FIZE kUO console 5G with power box US catalog number: FKUO5.0G_PB_US FIZE kUO console 5G with power supply US catalog number: FKUO5.0G_PS_US
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EXY | Uroflowmeter | Gastroenterology, Urology | 876.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47458 | Urine monitoring system | An assembly of devices intended to automatically and continuously monitor and display a patient's urine output (urine flow/volume). The system typically consists of a battery-powered, portable monitor with controls, digital display, alarms, and memory; an electronic (e.g., optical) urine output sensor; and a disposable urine collection container. The system is typically used in situations where fluid and renal management are critical to patient treatment and care [e.g., during diuresis monitoring in the intensive care unit (ICU)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290019239038 | GS1 | with power box | 1 | In Commercial Distribution | |
| Primary | 07290019239031 | GS1 | ||||
| Package | 27290019239035 | GS1 | with power supply | 1 | In Commercial Distribution |