ANALYZER 229047 WORLDWIDE

ANALYZER 229047 WORLDWIDE
NA - 229047

An electronic instrument designed to test an implanted cardiac pacemaker, including the lead/tissue interface at the time of implantation, for invasive pacemaker evaluation and/or during electrophysiology (EP) diagnostic procedures. It has testing and recording capabilities to measure the minimum electrical stimulus needed to elicit ventricular contraction and the minimum intracardiac signal amplitude needed to inhibit the pacemaker (i.e., stimulation and sensing thresholds respectively). It typically includes measuring devices for the bioelectrical signals, a pulse generator, controllers, and the capability to test the characteristics and performance of the implanted pacemaker.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OSR

Device Name: Pacemaker/Icd/Crt Non-Implanted Components

Device Class: 3

Physical State: Pacemaker/ICD/CRT non-implanted components can be separate pieces or integrated and usually include housings, electronics, processors, software, connectors, and cables.

Definition: Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Pacemaker/ICD/CRT non-implanted components transmit data from the implanted device to the health care provider using telemetry download, and direct or remote transmission.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Pacemaker/ICD/CRT devices are intended to provide therapy to the heart. The non-implanted components support the implanted devices.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: KRG

Device Name: Programmer, Pacemaker

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

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: 870.3700

Third Party Flag: N

Medical Specialty: CV

Device Id: 00721902256011

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