CardioInsight™

GUDID 00763000045425

SENSOR ARRAY VEST CITVST0001S US

MEDTRONIC, INC.

Cardiac mapping system electrode array

• Primary Device ID: 00763000045425
• NIH Device Record Key: 74a0e1d3-4d2e-435a-9610-e745283b332e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioInsight™
• Version Model Number: CITVST0001S
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000045425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162440

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-18
• Device Publish Date: 2018-08-18

On-Brand Devices [CardioInsight™]

• 00643169723689: SENSOR ARRAY VEST CITVST0004XL US
• 00643169723672: SENSOR ARRAY VEST CITVST0003L US
• 00643169723665: SENSOR ARRAY VEST CITVST0002M US
• 00643169723658: SENSOR ARRAY VEST CITVST0001S US
• 00643169723603: MAPPING SYSTEM CIT200 CIT US
• 00763000045456: SENSOR ARRAY VEST CITVST0004XL US
• 00763000045449: SENSOR ARRAY VEST CITVST0003L US
• 00763000045432: SENSOR ARRAY VEST CITVST0002M US
• 00763000045425: SENSOR ARRAY VEST CITVST0001S US