Identity
- Trade Name
- ATMOS Air-Charged Pressure Sensor FDA UDI
- Generic Name
- Air/gas pressure transducer FDA UDI
- Device Name
- 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, abdominal 2.5m for MMS FDA UDI
- Model / Reference
- PS11-21A25 FDA UDI
- 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, abdominal 2.5m for MMS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08594211570831 FDA UDI
- FDA Product Code
- FEN FDA UDI
- GMDN Term
- Air/gas pressure transducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1620 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
No
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
No
FDA UDI
Category: Air/gas pressure transducer
ATMOS Air-Charged Pressure Sensor by MEDKONSULT medical technology s.r.o. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air/gas pressure transducer.
- Patient Loading Utility System (PLUS) — LIFEPORT, LLC. · Class I
- MedPak — LIFEPORT, LLC. · Class II
- Air-Charged Reusable Cable — Laborie Medical Technologies Canada ULC · Class II
- MEDPAK — LIFEPORT, LLC. · Class I
- Air-Charged Reusable Cable — Laborie Medical Technologies Canada ULC · Class II
- Patient Loading Utility System (PLUS) — LIFEPORT, LLC. · Class I
- R-FLOWMETER — Ecleris · Class I
- BRAEBON PT2 Dual Differntial Airflow Pressure Kit — Braebon Medical Corp. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MEDKONSULT medical technology s.r.o.
Sources (1)
- FDA UDI 551ef8b0-a521-4bab-a8bb-db7ae5f9ca26 33 fields · synced Jun 1, 2026