Mikro-Tip Catheter Pulse Transducer 808-1019

GUDID 00868924000236

Mikro-Tip catheters consist of an ultra-miniature pressure sensor(s) at the distal end of a catheter with an electrical connector(s) at the proximal end. The pressure sensor produces an electrical output signal, which varies in direct proportion to the magnitude of sensed pressure or sound. Mikro-Tip catheters are intended for multiple uses.

MILLAR INC.

Catheter-tip transducer, pressure

• Primary Device ID: 00868924000236
• NIH Device Record Key: 55817e2f-4286-49a2-8ce2-c320f9ff4a43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mikro-Tip Catheter Pulse Transducer
• Version Model Number: SPT-301
• Catalog Number: 808-1019
• Company DUNS: 058269648
• Company Name: MILLAR INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868924000236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895721

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

Sterilization

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

[00868924000236]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-21

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: 2018-07-06 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: 2018-07-06Mikro-Tip catheters consist of an ultra-miniature pressure sensor(s) at the distal end of a catheter with an electrical connector(s) at the proximal end. The pressure sensor produces an electrical output signal, which varies in direct proportion to the magnitude of sensed pressure or sound. Mikro-Tip catheters are intended for multiple uses.
• 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