Advisa™ DR

GUDID 00643169050730

IPG A4DR01 ADVISA DR US MKT NON MRI

MEDTRONIC, INC.

Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive

• Primary Device ID: 00643169050730
• NIH Device Record Key: e3e75256-3d28-4129-abb5-a351f619172b
• Commercial Distribution Discontinuation: 2018-06-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Advisa™ DR
• Version Model Number: A4DR01
• 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: 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• 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 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169050730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980035

FDA Product Code

• NVZ: Pulse generator, permanent, implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

Devices Manufactured by MEDTRONIC, INC.

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• 00763000228699 - NA: 2024-07-08 KIT 20MRK ARCTIC FRNT MANETRACT GLB TIJ
• 00763000957193 - NA: 2024-07-08 CUSTOM PACK BB7M46R25 SCV ADLT
• 20763000960272 - NA: 2024-07-08 CUSTOM PACK 10R91R5 10PK LRTXBYPS
• 20763000960296 - NA: 2024-07-08 CUSTOM PACK SSBB12D06R4 4PK RESOXY BYPA
• 00763000879273 - Verify™: 2024-07-05 ENS 353101 VERIFY ISTM US EMANUAL
• 00763000879280 - Verify™: 2024-07-05 ENS 353101 VERIFY ISTM US REFURB EMAN