Device Description : The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure sensor near the distal end. The sensor is side mounted at the catheter tip. The proximal end terminates in a connector. The pressure sensor produces an electrical output signal which varies in direct proportion to the magnitude of sensed pressure or sound.
Device Class : 2
Duns Number: 058269648
Premarket Exempt : No
Prescription Use : Yes
Device Description : The twochannelPCU-2000, M.I. P/N 880-0129, is an essential interface between on The twochannelPCU-2000, M.I. P/N 880-0129, is an essential interface between one dual-pressure or twosingle-pressure Mikro-Tip catheters and a CE-approved data acquisition system or patient monitor. Theunit 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 patientsafety. These inputs are also protected against the effects of a cardiac defibrillator discharge. Thedischarge 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 monitorsand computer data acquisition systems. The amplifier provides bridge excitation voltage, separatebalance (zero) controls and lighted push buttons for electronic calibrations of 0, 25, 100 or 125 mmHgfor both channels.The PCU-2000 allows selection of standby mode to verify zero and calibration. The output connectorsare standard ¼-inch phone jacks. Output cables are not provided.
Device Class : 2
Duns Number: 058269648
Premarket Exempt : No
Prescription Use : No
Device Description : The TC-510 Pressure Control Unit is a passive interface between the pressure sen The TC-510 Pressure Control Unit is a passive interface between the pressure sensor of anystandardized sensitivity Mikro-Tip® catheter and strain gauge pressure monitors or recordingsystems which supply bridge excitation voltage and have balance and calibration controls forfull-bridge strain gauge pressure transducers.The TC-510 contains circuitry which facilitates monitor setup. In the STANDBY (0) positionthe TC-510 provides an electrical zero. In the 100 mmHg (13.3 kPa) position the TC-510provides a signal equal to 100 mmHg (13.3 kPa) at a sensitivity of 5 μV/V/mmHg. Thetransducer is operational in the TRANSDUCER position and the TRANSDUCER BALANCEcontrol allows balancing of the transducer
Device Class : 2
Duns Number: 058269648
Premarket Exempt : No
Prescription Use : No
Device Description : Mikro-Tip catheters consist of an ultra-miniature pressure sensor(s) at the dist Mikro-Tip catheters consist of an ultra-miniature pressure sensor(s) at the distal end of a catheter with an electrical connector(s) at the proximal end. The pressure sensor produces an electrical output signal, which varies in direct proportion to the magnitude of sensed pressure or sound. Mikro-Tip catheters are intended for multiple uses.
Device Class : 2
Duns Number: 058269648
Premarket Exempt : No
Prescription Use : Yes
Device Description : The 850-5148 cable is designed as an interface between the Millar Mikro-CathTM c The 850-5148 cable is designed as an interface between the Millar Mikro-CathTM catheter (Part #825-0101-5), and the Schwarzer Cardiotek GmbH medical device as detailed below: EP-Tracer 38, EP-Tracer 70, EP-Tracer 102, when used with the following system configurations: EP-Tracer Portable, EP-Tracer Stationary, EP-Tracer ProCart. The 850-5148 cable is 10 feet long. The cable is supplied nonsterile.
Device Class : 2
Duns Number: 058269648
Premarket Exempt : No
Prescription Use : Yes