Therapy™ IBI-83719

GUDID 05414734308335

IRVINE BIOMEDICAL, INC.

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

• Primary Device ID: 05414734308335
• NIH Device Record Key: 04a57456-7a3b-44ec-ba00-85c6a268f67d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Therapy™
• Version Model Number: IBI-83719
• Catalog Number: IBI-83719
• 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 *Keep cool and dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734308335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040014

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: 3
• Public Version Date: 2019-01-28
• Device Publish Date: 2014-10-31

On-Brand Devices [Therapy™]

• 05415067019875: Cool Path™
• 05415067004574: Ablation Catheter
• 05415067004567: Ablation Catheter
• 05415067004550: Ablation Catheter
• 05415067004543: Ablation Catheter
• 05414734310680: Ablation Catheter
• 05414734310673: Ablation Catheter
• 05414734310666: Ablation Catheter
• 05414734310659: Ablation Catheter
• 05414734308595: Cool Path™
• 05414734308588: Cool Path™
• 05414734308571: Cool Path™
• 05414734308564: Cool Path™
• 05414734308403: IBI-83726
• 05414734308397: Ablation Catheter
• 05414734308380: IBI-83724
• 05414734308359: Ablation Catheter
• 05414734308342: IBI-83720
• 05414734308335: IBI-83719
• 05414734307598: IBI-83445
• 05414734307581: 8mm Tip Thermistor Ablation Catheter
• 05414734307567: IBI-83442
• 05414734307550: 8mm Tip Thermistor Ablation Catheter
• 05414734307024: Ablation Catheter
• 05414734307017: Dual 8™
• 05414734307000: Dual-8™
• 05414734306997: Dual-8™
• 05414734306980: Dual-8™
• 05414734306973: Ablation Catheter
• 05414734306959: IBI-83368
• 05414734306942: Ablation Catheter
• 05414734306935: IBI-83366
• 05414734306928: IBI-83365
• 05414734306911: IBI-83364
• 05414734306737: Cool Path™
• 05414734306720: Cool Path™
• 05414734306713: Cool Path™
• 05414734306706: Cool Path™