The twochannel PCU-2000, M.I. P/N 880-0129, is an essential interface between one dual-pressure or two single-pressure Mikro-Tip catheters and a CE-approved data acquisition system or…
The twochannel PCU-2000, M.I. P/N 880-0129, is an essential interface between one dual-pressure or two single-pressure Mikro-Tip catheters and a CE-approved data acquisition system or patient monitor. The unit is powered by a Millar-supplied external AC/DC power supply. The PCU-2000 pressure inputs (input channel 1 and input channel 2) are electrically isolated for patient safety. These inputs are also protected against the effects of a cardiac defibrillator discharge. The discharge of a cardiac defibrillator has no effect on the operation of the PCU-2000. The pressure outputs have a sensitivity of 1V/100mmHg, which is ideally compatible with most monitors and computer data acquisition systems. The amplifier provides bridge excitation voltage, separate balance (zero) controls and lighted push buttons for electronic calibrations of 0, 25, 100 or 125 mmHg for both channels. The PCU-2000 allows selection of standby mode to verify zero and calibration. The output connectors are standard ¼-inch phone jacks. Output cables are not provided.
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Pressure Control Unit PCU-2000 | Listed by | Millar LLC., United States |
| FDA product code | DRQ |
| Device type | Amplifier And Signal Conditioner, Transducer Signal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2060 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K013205 |
| Record published | 2016-09-30 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | serial number |
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.