- Physicians Office Resource

Celsius RMT ThermoCool - CR7TCSIRT

Device Description

A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Do not use if package is damaged

Special Storage Condition, Specify

Do not use if package is opened

Special Storage Condition, Specify

Keep out of direct sunlight

Special Storage Condition, Specify

Keep Dry

Storage Environment Temperature - Degrees Celsius

25.00
5.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OAD

Device Name: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Device Class: 3

Physical State: The device is an ablation catheter that features electrodes through which thermal energy is delivered.

Definition: For the treatment of atrial flutter.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The ablation catheter delivers energy to the specific region of the heart in order to create lesions that will treat the patient of atrial flutter.

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: Heart

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 10846835003901

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

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