Safire™

Basic Information

• Brand Name: Safire™
• Primary DI: 05414734206037
• Version / Model: 402812
• Catalog Number: 402812
• Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
• Labeler DUNS: 040960379
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-23
• Public Version: 4
• Public Version Date: 2019-01-28
• Public Version Status: Update
• Public Device Record Key: 4927df84-ca71-48e1-863e-765c684f01e7
• Distribution End Date: 2018-04-05

Device Description

Bi-Directional Ablation Catheter

Device Characteristics

• Single Use: Yes
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPB	Cardiac ablation percutaneous catheter	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61785	Cardiac radio-frequency ablation system catheter	A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414734206037	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P960016	014

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	7	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry, keep out of sunlight, and keep away from heat and radiation.