CABLE 2090ECL 14FT ECG W/CONN CVR
NA - 2090ECL
Device Description
A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.
Environmental Conditions
- 95.00
- N/A
- 158.00
- -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: 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: 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: 00721902283819
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