NBIH Temporary Pacing Electrode Catheter, Bipolar
NBIH™ Temporary Pacing Electrode Catheter - 057153P
Device Description
A sterile, flexible 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 which generates the electrical pacing impulses. It may be unipolar or bipolar and facilitates the display of the electrocardiographic signal. 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.
Environmental Conditions
No Data Available
Device Sizes
- Length: 125 Centimeter
- Catheter Gauge: 6 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 10801741011488
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00801741011481
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CA
Device Id: 00801741011481
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