SENSOR ARRAY VEST CITVST0004XL US
CardioInsight™ - CITVST0004XL
Device Description
A non-sterile, noninvasive component of a cardiac mapping system intended to be worn on the torso to transmit cardiac bioelectric signals to the system for storage, analysis and display of cardiac electrophysiological data. It is typically in the form of a vest consisting of multiple layers including textile, polymer and electrically-conducting materials in discreet electrodes. This is a single-use device.
Environmental Conditions
- Keep Dry
- 86.00
- 59.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 00643169723689
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