CardioInsight™

Basic Information

• Brand Name: CardioInsight™
• Primary DI: 00643169723665
• Version / Model: CITVST0002M
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-02
• Public Version: 4
• Public Version Date: 2019-06-13
• Public Version Status: Update
• Public Device Record Key: 177ac703-fab2-457b-9274-f1e3c7d9f1c1
• Distribution End Date: 2019-06-04

Device Description

SENSOR ARRAY VEST CITVST0002M US

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQK	COMPUTER, DIAGNOSTIC, PROGRAMMABLE	Cardiovascular	870.1425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61843	Cardiac mapping system electrode array	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169723665	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K162440	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit