Cool Path™ A700241

GUDID 05415067002419

IRVINE BIOMEDICAL, INC.

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

• Primary Device ID: 05415067002419
• NIH Device Record Key: 0907b983-ca75-4af5-84f8-c856d6e6cb69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cool Path™
• Version Model Number: Duo, MediGuide Enabled™
• Catalog Number: A700241
• 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry location.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067002419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110016

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 [Cool Path™ ]

• 05415067002440: Duo, MediGuide Enabled™
• 05415067002433: Duo, MediGuide Enabled™
• 05415067002426: Duo, MediGuide Enabled™
• 05415067002419: Duo, MediGuide Enabled™