FDA UDI
In Commercial Distribution
🇺🇸 United States
ATMOS Air-Charged Pressure Sensor
DI: 08594211570893
·
Model: PS11-21V25
·
MEDKONSULT medical technology s.r.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ATMOS Air-Charged Pressure Sensor
- Primary DI
- 08594211570893
- Version / Model
- PS11-21V25
- 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
- 2024-11-06
- Public Version
- 1
- Public Version Date
- 2024-11-14
- Public Version Status
- New
- Public Device Record Key
- 4c13a866-4cfb-47a0-beeb-cc62fc001369
Device Description
Air-Charged Pressure Sensor intended for measurement of urodynamic pressures transmitted by approved types of measuring, air-filled catheters in a set of specified urodynamic measurement systems, vesical 2.5m for MMS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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
- Yes
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FEN | Device, Cystometric, Hydraulic | Gastroenterology, Urology | 876.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31278 | Air/gas pressure transducer | A noninvasive electronic device designed to convert air or gas pressure signals into electrical signals for subsequent display or processing by a parent device (e.g., physiological data recorder, gastrointestinal motility analysis system). It may be a compact unit or included in an electrical cable, and receives pressure signals from connected pressure-measuring devices (e.g., urodynamic air-charged catheter, monitoring respiratory tubing). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08594211570893 | GS1 |