CARDIOBLATE®

Basic Information

• Brand Name: CARDIOBLATE®
• Primary DI: 00721902709340
• Version / Model: 60813
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-16
• Public Version: 7
• Public Version Date: 2024-02-08
• Public Version Status: Update
• Public Device Record Key: 293972e1-e9fd-4010-b273-de698594c0c5

Device Description

ABLATION PEN 60813 CARDIOBLATE N-PMP

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCL	Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60784	Cardiac radio-frequency ablation system generator	An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00721902709340	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K013392	000
K070288	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 85 Percent (%) Relative Humidity