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Pressure Control Unit PCU-2000

FDA UDI

Class II (US FDA UDI)

by Millar LLC.

Identity

Trade Name
Pressure Control Unit PCU-2000 FDA UDI
Generic Name
Transducer signal amplifier FDA UDI
Device Name
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. FDA UDI
Model / Reference
PCU-2000 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
880-0129 FDA UDI
Primary DI / UDI-DI
00868924000212 FDA UDI
510(k) Number
K013205 FDA UDI
FDA Product Code
DRQ FDA UDI
GMDN Term
Transducer signal amplifier FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2060 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Transducer signal amplifier

Pressure Control Unit PCU-2000 by Millar LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transducer signal amplifier.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Millar LLC.

Sources (1)

  • FDA UDI a288ec2f-2e92-4d20-bb06-65e35d59affc 35 fields · synced May 30, 2026