TUBING SET AFR-00002 HEXAFLOW 4PK US

TUBING SET AFR
NA - AFR-00002

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 Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

Code: QZI

Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Device Class: 3

Physical State: The device is an ablation catheter that features electrodes through which pulsed electric fields are delivered.

Definition: For the treatment of atrial fibrillation.

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 fibrillation.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Heart

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: OAE

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

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 fibrillation.

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 fibrillation.

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 Id: 20763000871776

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00763000871772

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PK

Device Id: 00763000871772

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