Mikro-Cath Pressure Catheter 825-0101

GUDID 00868924000205

The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure sensor near the distal end. The sensor is side mounted at the catheter tip. The proximal end terminates in a connector. The pressure sensor produces an electrical output signal which varies in direct proportion to the magnitude of sensed pressure or sound.

MILLAR INC.

Catheter-tip transducer, pressure

• Primary Device ID: 00868924000205
• NIH Device Record Key: 2a5b4aff-2b15-48ba-96d1-97e4d9830d8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mikro-Cath Pressure Catheter
• Version Model Number: 825-0101
• Catalog Number: 825-0101
• Company DUNS: 058269648
• Company Name: MILLAR INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 832-667-7131
• Email: jjean-baptiste@millar.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868924000205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093111

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-03

Devices Manufactured by MILLAR INC.

• 00868924000267 - Monitor Input Cable, Mikro-Cath to EP-Tracer System: 2021-07-26 The 850-5148 cable is designed as an interface between the Millar Mikro-CathTM catheter (Part #825-0101-5), and the Schwarzer Ca
• 00868924000205 - Mikro-Cath Pressure Catheter: 2018-07-06The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure sensor near the distal end. The sensor is side mounted at the catheter tip. The proximal end terminates in a connector. The pressure sensor produces an electrical output signal which varies in direct proportion to the magnitude of sensed pressure or sound.
• 00868924000205 - Mikro-Cath Pressure Catheter: 2018-07-06 The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure sensor near the distal end. The sensor
• 00868924000212 - Pressure Control Unit PCU-2000: 2018-07-06 The twochannel PCU-2000, M.I. P/N 880-0129, is an essential interface between one dual-pressure or two single-pressure Mikro-Ti
• 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®
• 00868924000236 - Mikro-Tip Catheter Pulse Transducer: 2018-07-06 Mikro-Tip catheters consist of an ultra-miniature pressure sensor(s) at the distal end of a catheter with an electrical connecto