Safire™ 402812

GUDID 05414734206037

Bi-Directional Ablation Catheter

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Cardiac radio-frequency ablation system catheter

• Primary Device ID: 05414734206037
• NIH Device Record Key: 4927df84-ca71-48e1-863e-765c684f01e7
• Commercial Distribution Discontinuation: 2018-04-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Safire™
• Version Model Number: 402812
• Catalog Number: 402812
• Company DUNS: 040960379
• Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 7 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight, and keep away from heat and radiation.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734206037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960016

FDA Product Code

• LPB: Cardiac ablation percutaneous catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-28
• Device Publish Date: 2014-09-23

On-Brand Devices [Safire™]

• 05414734217446: 402570
• 05414734217439: 402569
• 05414734217422: 402554
• 05414734217415: 402553
• 05414734217385: 402550
• 05414734217378: 402549
• 05414734206082: 402817
• 05414734206075: 402816
• 05414734206068: 402815
• 05414734206051: 402814
• 05414734206044: 402813
• 05414734206037: Bi-Directional Ablation Catheter
• 05414734206020: 402811
• 05414734206013: 402810
• 05414734206006: 402809
• 05414734205993: 402808
• 05414734205986: 402807
• 05414734205979: 402806