PATCH AFR-00007 LOCATION REF 4PK US

PATCH AFR
NA - AFR-00007

A component of a cardiac mapping system that is an adhesive device placed on the surface of a patient's body, typically the chest and/or back, to provide a fixed reference point for the tip of an internal, non-fluoroscopic catheter during an electrophysiological and electromechanical real-time mapping of the heart. It may be sensor-containing or have a sensor attached to it, and is used to compensate for patient movement during the procedure. It is typically used with a cardiac mapping system computer to assist in the location and navigation of the catheter tip, and to provide electrocardiogram information. This is a single-use device.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DQK

Device Name: Computer, Diagnostic, Programmable

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: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.1425

Third Party Flag: Y

Medical Specialty: CV

Device Id: 20763000871837

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00763000871833

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PK

Device Id: 00763000871833

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