HeartLight 18-3055

GUDID 00868976000154

Laser Ablation Console

CARDIOFOCUS, INC.

Cardiac ablation solid-state laser system

• Primary Device ID: 00868976000154
• NIH Device Record Key: 37bebfd6-9ec7-41de-a848-dfaffd163767
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartLight
• Version Model Number: CF980-E10-US
• Catalog Number: 18-3055
• Company DUNS: 068966261
• Company Name: CARDIOFOCUS, 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: true
• 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: +1(844)527-3723
• Email: customerservice@cardiofocus.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868976000154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150026

FDA Product Code

• OAE: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

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: 2016-06-15

On-Brand Devices [HeartLight]

• 00868976000178: Endoscopic Ablation Catheter
• 00868976000161: Endoscopic Ablation Console (JP)
• 00868976000154: Laser Ablation Console
• 00868976000147: Deflectable Sheath
• 00868976000130: Balloon Fill Media
• 00868976000123: Endoscope
• 00868976000116: Endoscopic Ablation Console (EU)
• 00868976000109: Laser Ablation Balloon Catheter