TC-510 Pressure Control Unit 851-5918

GUDID 00868924000229

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

MILLAR INC.

Transducer signal amplifier

• Primary Device ID: 00868924000229
• NIH Device Record Key: 70df8f19-161c-43b2-878b-276b7129a0de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TC-510 Pressure Control Unit
• Version Model Number: TC-510
• Catalog Number: 851-5918
• Company DUNS: 058269648
• Company Name: MILLAR INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 832-667-7000
• Email: sales@millar.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868924000229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K842150

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-30

Devices Manufactured by MILLAR INC.

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• 00868924000229 - TC-510 Pressure Control Unit: 2018-07-06The 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
• 00868924000229 - TC-510 Pressure Control Unit: 2018-07-06 The TC-510 Pressure Control Unit is a passive interface between the pressure sensor of any standardized sensitivity Mikro-Tip®
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