Pressure Control Unit PCU-2000
Basic Information
- Brand Name
- Pressure Control Unit PCU-2000
- Primary DI
- 00868924000212
- Version / Model
- PCU-2000
- Catalog Number
- 880-0129
- Company Name
- MILLAR INC.
- Labeler DUNS
- 058269648
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a288ec2f-2e92-4d20-bb06-65e35d59affc
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | Cardiovascular | 870.2060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46250 | Transducer signal amplifier | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868924000212 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013205 | 000 |