Cool Point™ 85785

GUDID 05414734258616

Irrigation Pump Tubing Set

IRVINE BIOMEDICAL, INC.

Cardiac ablation system irrigation tubing set

• Primary Device ID: 05414734258616
• NIH Device Record Key: 2354965d-9f38-42fd-b5e5-f43927c91930
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cool Point™
• Version Model Number: 85785
• Catalog Number: 85785
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734258616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060019

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 Point™]

• 05415067008985: Irrigation Pump
• 05414734258616: Irrigation Pump Tubing Set
• 05415067016669: Pressure Alarm Adapter Cable