Solara™ CRT-P MRI SureScan™

GUDID 00643169891449

CRTP W1TR03 SOLARA CRTP MRI US

MEDTRONIC, INC.

Cardiac resynchronization therapy implantable pacemaker

• Primary Device ID: 00643169891449
• NIH Device Record Key: 36555fd9-e2c1-4325-ae03-1b5ef1e3f4d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solara™ CRT-P MRI SureScan™
• Version Model Number: W1TR03
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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
• 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
• 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
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169891449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010015

FDA Product Code

• NKE: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-10-20

On-Brand Devices [Solara™ CRT-P MRI SureScan™]

• 00643169891449: CRTP W1TR03 SOLARA CRTP MRI US
• 00643169735675: CRTP W1TR03 SOLARA CRTP MRI US