Pressure Control Unit PCU-2000 - The twochannelPCU-2000, M.I. P/N 880-0129, is an - MILLAR INC.

Duns Number:058269648

Device Description: The twochannelPCU-2000, M.I. P/N 880-0129, is an essential interface between one dual-pre 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.

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More Product Details

Catalog Number

880-0129

Brand Name

Pressure Control Unit PCU-2000

Version/Model Number

PCU-2000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K013205

Product Code Details

Product Code

DRQ

Product Code Name

Amplifier And Signal Conditioner, Transducer Signal

Device Record Status

Public Device Record Key

a288ec2f-2e92-4d20-bb06-65e35d59affc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MILLAR INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5