MAGNET 9322 DISABLER SMART MAGNET US

MAGNET 9322 DISABLER SMART MAGNET US
SMARTMAGNET™ - 9322

A magnetized device used to test an inhibited or triggered type of pacemaker or defibrillator, and cause an inhibited or triggered generator to revert to asynchronous operation. The device is placed on the outside of the patient's thorax over the pacemaker/defibrillator for analysis of the implanted device's function. The magnet will activate the magnet sensitive relay in the pacemaker/defibrillator and will change the function of the implanted device. It is possible to evaluate the function of the implanted device via an electrocardiograph.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LWS

Device Name: Implantable Cardioverter Defibrillator (Non-Crt)

Device Class: 3

Physical State: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Definition: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: NIK

Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Device Class: 3

Physical State: These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.

Definition: These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00681490197885

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