HeartLight

Basic Information

• Brand Name: HeartLight
• Primary DI: 00868976000116
• Version / Model: 18-2959
• Catalog Number: 18-2959
• Company Name: CARDIOFOCUS, INC.
• Labeler DUNS: 068966261
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-03
• Public Version: 1
• Public Version Date: 2018-11-05
• Public Version Status: New
• Public Device Record Key: 4717540d-25df-4e01-9bc6-89c1c29eb8bf

Device Description

Endoscopic Ablation Console (EU)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61969	Cardiac ablation solid-state laser system	A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a doped glass/crystal medium to emit a high-power laser beam intended for endocardial ablation procedures for the treatment of atrial fibrillation; the therapeutic laser does not include frequency-doubling technology. It includes a laser generator with controls and monitor. It is intended to function with a laser beam-guide catheter (typically introduced to the pulmonary vein via transseptal access) and a flexible video angioscope for visualization during the procedure; the catheter and angioscope may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00868976000116	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P150026	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: noncondensing
• Type: Storage Environment Humidity
• Temperature Range: 0 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -25 – 55 Degrees Celsius