CardioSight™ Reader

GUDID 00643169312098

MON 2020A2 CARDIOSIGHT 60601 3ED USA

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use

• Primary Device ID: 00643169312098
• NIH Device Record Key: 65e36b89-39ee-4583-b42f-2897b0b0bec8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioSight™ Reader
• Version Model Number: 2020A2
• 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: false
• Lot Batch: false
• Serial Number: true
• 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 -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169312098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P890003

FDA Product Code

• NVZ: Pulse generator, permanent, implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

Devices Manufactured by MEDTRONIC, INC.

• 00763000835392 - HawkOne™: 2025-01-06 ATHERECTOMY H1-14550 CUTTER DRIVER UNI
• 00763000989224 - NA: 2025-01-06 CUSTOM PACK BB12B64R6 GOLD H/L PACK
• 00763000990060 - NA: 2025-01-06 CUSTOM PACK BB12M44R UMCEP SHUNT PK
• 20763000990088 - NA: 2025-01-06 CUSTOM PACK 9D70R2 10PK HDR PK
• 20763000990460 - NA: 2025-01-06 CUSTOM PACK BB12M56R 10PK 1/4 SUPPLEMENT
• 20763000990484 - NA: 2025-01-06 CUSTOM PACK BB12M39R 2PK PACK C STRAIGH
• 20763000990507 - NA: 2025-01-06 CUSTOM PACK 11C82R1 4PK CARDIOPLEG
• 00763000990510 - NA: 2025-01-06 CUSTOM PACK BB11Y33R6 PED SM ADT