AccessGUDID - DEVICE: TC-510 Pressure Control Unit (00868924000229)

GUDID

Device Identifier (DI) Information

Brand Name: TC-510 Pressure Control Unit
Version or Model: TC-510
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 851-5918
Company Name: MILLAR INC.

Primary DI Number: 00868924000229
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058269648 *Terms of Use

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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXO	Transducer, Pressure, Catheter Tip

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K842150	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 70df8f19-161c-43b2-878b-276b7129a0de
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 30, 2016