N/A - CEDTC100
Device Description
A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a previously used single-use device that has been processed for an additional single-use patient application.
Environmental Conditions
No Data Available
Device Sizes
- Length: 8.2 Feet
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: IKD
Device Name: Cable, Electrode
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: PM
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: 890.1175
Third Party Flag: N
Medical Specialty: PM
Device IdentifiersDevice Id: 57613327643232
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613327643237
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: case
Device Id: 07613327643237
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