EPstar Fixed Electrophysiology Catheter with Lumen

GUDID 00685447003731

Max guidewire OD 0.035”; 10 electrodes; Electrode spacing: 5-5-5 mm

Baylis Médicale Cie Inc

Cardiac mapping catheter, percutaneous, single-use

• Primary Device ID: 00685447003731
• NIH Device Record Key: 7a93b66c-3cff-4418-8dfc-a4148b673da2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPstar Fixed Electrophysiology Catheter with Lumen
• Version Model Number: DLF-6-10-55-65
• Company DUNS: 249225954
• Company Name: Baylis Médicale Cie 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com

Device Dimensions

• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French
• Length: 65 Centimeter
• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447003731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183632

FDA Product Code

• DRF: Catheter, Electrode Recording, Or Probe, Electrode Recording

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-09
• Device Publish Date: 2019-08-30

On-Brand Devices [EPstar Fixed Electrophysiology Catheter with Lumen]

• 00685447003731: Max guidewire OD 0.035”; 10 electrodes; Electrode spacing: 5-5-5 mm
• 00685447003724: Max guidewire OD 0.035”; 10 electrodes; Electrode spacing: 2-8-2 mm
• 00685447005995: Max guidewire OD 0.035”; 11 electrodes; Electrode spacing: 5-5-5 mm