Consulta® CRT-P

GUDID 00613994713667

CRT C4TR01 CONSULTA CRT-P US MR

MEDTRONIC, INC.

Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker

• Primary Device ID: 00613994713667
• NIH Device Record Key: ee35bcab-7776-4675-94f9-d63ab466f7c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Consulta® CRT-P
• Version Model Number: C4TR01
• 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

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994713667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010015

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: 2019-06-28
• Device Publish Date: 2014-09-23

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