Pressure Control Unit PCU-2000

Primary DI
00868924000212
Brand
Pressure Control Unit PCU-2000
Company
MILLAR INC.
Model
PCU-2000
Catalog number
880-0129
Device description
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.
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DRQAmplifier And Signal Conditioner, Transducer Signal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRQAmplifier And Signal Conditioner, Transducer SignalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013205000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013205000MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000Millar Instruments, Inc.2002-07-02DRQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868924000212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868924000212008689240002128689240002120868924000212

GMDN Terms#

Term, Definition table
TermDefinition
Transducer signal amplifierAn electronic device that increases current, voltage, or power to intensify the electrical signal sent to or received from a transducer (e.g., electroacoustic, electro-optical, electromechanical), sometimes providing impedance matching. It will provide an electrical interface between a physiological transducer and a patient monitor or patient monitoring system that is used to monitor pressures such as, noninvasive and invasive blood pressure, oesophageal pressures, urinary tract pressures, intrauterine pressures and intraocular pressures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058269648
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868924000267Monitor Input Cable, Mikro-Cath to EP-Tracer System850-5148850-51482021-07-16
00868924000205Mikro-Cath Pressure Catheter825-0101825-01012016-10-03
00868924000229TC-510 Pressure Control UnitTC-510851-59182016-09-30
00868924000236Mikro-Tip Catheter Pulse TransducerSPT-301808-10192016-10-21

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