Balloon Bipolar Temporary Pacing Electrode Catheter, Stainless Steel Electrodes

Balloon Bipolar Temporary Pacing Electrode Catheter, Stainless Steel Electrodes
N/A - 006172P

A sterile, flexible, balloon-tipped, tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker that generates the electrical pacing impulses. It may be unipolar or bipolar and facilitate the display of electrocardiographic signals. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device.

No Data Available

• Length: 110 Centimeter
• Catheter Gauge: 4 French

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LDF

Device Name: Electrode, Pacemaker, Temporary

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: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.3680

Third Party Flag: N

Medical Specialty: CV

Device Id: 10801741011198

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741011191

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 00801741011191

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