CoolFlow

Basic Information

• Brand Name: CoolFlow
• Primary DI: 10846835000016
• Version / Model: CFT001
• Catalog Number: CFT001
• Company Name: Biosense Webster Inc
• Labeler DUNS: 020163218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-10
• Public Version: 6
• Public Version Date: 2022-06-07
• Public Version Status: Update
• Public Device Record Key: 967ebd67-718e-4387-9580-db537b537665

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING	Cardiovascular	870.1220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44772	Cardiac ablation system irrigation tubing set	A collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10846835000016	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P990071	005

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is opened
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged
• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry