Atmos Air-Charged Pressure Sensor
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…
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 0.5m for Harmony
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
Record
| Listed by | Medkonsult Medical Technology S.R.O., Czechia |
|---|---|
| FDA product code | FEN |
| Device type | Device, Cystometric, Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1620 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-11-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PS11-21V25 | In distribution | |
| PS11-21A25 | In distribution | |
| PS11-01R25 | In distribution | |
| PS11-01A25 | In distribution | |
| PS11-11V25 | In distribution | |
| PS11-11U05 | In distribution | |
| PS11-11U25 | In distribution | |
| PS11-02A05 | In distribution | |
| PS11-02R05 | In distribution | |
| PS11-21A05 | In distribution | |
| PS11-21R25 | In distribution | |
| PS11-11A05 | In distribution | |
| PS11-21R05 | In distribution | |
| PS11-01V25 | In distribution | |
| PS11-21U05 | In distribution | |
| PS11-11R25 | In distribution | |
| PS11-11R05 | In distribution | |
| PS11-21V05 | In distribution | |
| PS11-01U25 | In distribution | |
| PS11-11A25 | In distribution | |
| PS11-11V05 | In distribution | |
| PS11-21U25 | In distribution | |
| PS11-02U05 | In distribution | |
| PS11-02V05 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Air-Charged Reusable Cable | Laborie Medical Technologies, Canada ULC | 63 |
| Mediplus | Mediplus Ltd. | 45 |
| UniTip Catheter | Unisensor AG | 45 |
| Porges Coloplast | Coloplast A/S | 13 |
| Abviser | Convatec, Purchasing Department | 9 |
| NXT | Laborie Medical Technologies Corp. | 7 |
| Pump Tube Set | Laborie Medical Technologies, Canada ULC | 7 |
| Cystometry Pack | Laborie Medical Technologies, Canada ULC | 7 |
| Lumax TS Pro | Coopersurgical, Inc. | 6 |
| Bard® Urodynamic Catheter, Triple Lumen | C.R. Bard, Inc. | 6 |
| e∙Sense | Pendracare International B.V. | 5 |
| Timm | Mediplus Ltd. | 4 |
Showing 12 of 238. All products under Device, Cystometric, Hydraulic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.