Consulta® CRT-P

GUDID 00613994713667

CRT C4TR01 CONSULTA CRT-P US MR

MEDTRONIC, INC.

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

Devices Manufactured by MEDTRONIC, INC.

• 00763000893910 - SHERPA NX BALANCED™: 2024-12-20 CATHETER SB6FL40SH SB 6F 100CM FL40
• 00763000893941 - SHERPA NX BALANCED™: 2024-12-20 CATHETER SB6FR40SH SB 6F 100CM FR40
• 00763000988258 - NA: 2024-12-20 CUSTOM PACK BB10Q85R1 FILTER
• 00763000988760 - NA: 2024-12-20 CUSTOM PACK BB1F66R26 CASPER
• 00763000973391 - Sphere-9™ Catheter: 2024-12-16 CATHETER AFR-00001 SPHERE 9 Q-US AFR
• 00763000986704 - NA: 2024-12-09 CUSTOM PACK BB7J97R20 1/4 PED CIRC
• 00763000986773 - NA: 2024-12-09 CUSTOM PACK BB11N26R12 MASTER PACK
• 20763000986814 - NA: 2024-12-09 CUSTOM PACK BB12G70R3 10PK SUPPLIES