FDA UDI
In Commercial Distribution
🇺🇸 United States
UROMIC Symphony
DI: 08594211570169
·
Model: FU5000
·
MEDKONSULT medical technology s.r.o.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UROMIC Symphony
- Primary DI
- 08594211570169
- Version / Model
- FU5000
- Catalog Number
- FU5000
- Company Name
- MEDKONSULT medical technology s.r.o.
- Labeler DUNS
- 361814147
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-27
- Public Version
- 1
- Public Version Date
- 2022-06-06
- Public Version Status
- New
- Public Device Record Key
- 2950dbcf-e5c9-4b6b-8b4b-1130169e4f64
Device Description
The UROMIC Symphony is one of MMT's (MEDKONSULT medical technology s.r.o.) Urodynamic family of medical device. The UROMIC Symphony (FU5000) is a modular urodynamic measuring system for complex urodynamic examinations.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14307 | Urodynamic measurement system | An assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry (measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). Long-term recording may also be analysed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08594211570169 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 45 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- – 75 Percent (%) Relative Humidity