CoolFlow - CFT001
Device Description
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.
Environmental Conditions
- Do not use if package is opened
- Do not use if package is damaged
- Keep out of direct sunlight
- Keep Dry
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DRF
Device Name: Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1220
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 10846835000016
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A