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.
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
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013205
Product Code
DRQ
Product Code Name
Amplifier And Signal Conditioner, Transducer Signal
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |