Safire™ TX 402839

GUDID 05414734300155

IRVINE BIOMEDICAL, INC.

Cardiac mapping/radio-frequency ablation catheter, single-use

• Primary Device ID: 05414734300155
• NIH Device Record Key: 5138558c-faa8-4350-be35-f6aa6d9fc3f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safire™ TX
• Version Model Number: 402839
• Catalog Number: 402839
• Company DUNS: 926346966
• Company Name: IRVINE BIOMEDICAL, INC.
• 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 *Store in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734300155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040042

FDA Product Code

• OAD: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-28
• Device Publish Date: 2014-09-29

On-Brand Devices [Safire™ TX]

• 05414734300278: Ablation Catheter
• 05414734300261: 402579
• 05414734300254: 402578
• 05414734300247: 402577
• 05414734300193: 402843
• 05414734300186: 402842
• 05414734300179: 402841
• 05414734300162: 402840
• 05414734300155: 402839