MON 2020B3 CARELINK USA BW 60601
MEDTRONIC CARELINK EXPRESS™ - 2020B3
Device Description
An external device intended to enable a layperson to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to provide historic and/or current information on device performance, and may in addition be intended to communicate with a diagnostic cardiac implant (e.g., implantable cardiac monitor); it is not intended to program therapeutic implants and is dedicated to cardiac use. It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. This is a home-use device.
Environmental Conditions
- 95.00
- N/A
- 150.00
- -40.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NVZ
Device Name: Pulse Generator, Permanent, Implantable
Device Class: 3
Physical State: A hermetically sealed outer can (usually metallic) houses electronic circuitry and allows for connection to pacing leads (electrodes).
Definition: Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
Submission Type ID: 2
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Used as part of a pacing system that consists of a pulse generator and a lead, and which may also require an external pacemaker programmer.
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Implanted in the chest or abdomen, and makes contact with cardiac tissue via pacing leads.
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 00643169192058
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