Pressure Control Unit PCU-2000 880-0129

GUDID 00868924000212

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.

MILLAR INC.

Transducer signal amplifier

• Primary Device ID: 00868924000212
• NIH Device Record Key: a288ec2f-2e92-4d20-bb06-65e35d59affc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pressure Control Unit PCU-2000
• Version Model Number: PCU-2000
• Catalog Number: 880-0129
• Company DUNS: 058269648
• Company Name: MILLAR INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868924000212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013205

FDA Product Code

• DRQ: Amplifier And Signal Conditioner, Transducer Signal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-30

Devices Manufactured by MILLAR INC.

• 00868924000267 - Monitor Input Cable, Mikro-Cath to EP-Tracer System: 2021-07-26 The 850-5148 cable is designed as an interface between the Millar Mikro-CathTM catheter (Part #825-0101-5), and the Schwarzer Ca
• 00868924000205 - Mikro-Cath Pressure Catheter: 2018-07-06 The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure sensor near the distal end. The sensor
• 00868924000212 - Pressure Control Unit PCU-2000: 2018-07-06 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.
• 00868924000212 - Pressure Control Unit PCU-2000: 2018-07-06 The twochannel PCU-2000, M.I. P/N 880-0129, is an essential interface between one dual-pressure or two single-pressure Mikro-Ti
• 00868924000229 - TC-510 Pressure Control Unit: 2018-07-06 The TC-510 Pressure Control Unit is a passive interface between the pressure sensor of any standardized sensitivity Mikro-Tip®
• 00868924000236 - Mikro-Tip Catheter Pulse Transducer: 2018-07-06 Mikro-Tip catheters consist of an ultra-miniature pressure sensor(s) at the distal end of a catheter with an electrical connecto