TC-510 Pressure Control Unit

Basic Information

• Brand Name: TC-510 Pressure Control Unit
• Primary DI: 00868924000229
• Version / Model: TC-510
• Catalog Number: 851-5918
• 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: 70df8f19-161c-43b2-878b-276b7129a0de

Device Description

The TC-510 Pressure Control Unit is a passive interface between the pressure sensor of any standardized sensitivity Mikro-Tip® catheter and strain gauge pressure monitors or recording systems which supply bridge excitation voltage and have balance and calibration controls for full-bridge strain gauge pressure transducers. The TC-510 contains circuitry which facilitates monitor setup. In the STANDBY (0) position the TC-510 provides an electrical zero. In the 100 mmHg (13.3 kPa) position the TC-510 provides a signal equal to 100 mmHg (13.3 kPa) at a sensitivity of 5 μV/V/mmHg. The transducer is operational in the TRANSDUCER position and the TRANSDUCER BALANCE control allows balancing of the transducer

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
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	870.2870	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	00868924000229	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K842150	000