GUDID 00643169195844

CONSOLE 106A3 GEN V CRYO US LOANER

MEDTRONIC, INC.

Cardiac cryosurgical system

• Primary Device ID: 00643169195844
• NIH Device Record Key: 59d7b17c-f90a-45c9-aa4c-01985b8facf5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 106A3
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169195844 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020045

FDA Product Code

• LPB: Cardiac ablation percutaneous catheter

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.

• 00199150029815 - NA: 2025-07-18 CUSTOM PACK BB9J91R11 CP PRIME
• 00199150029839 - NA: 2025-07-18 CUSTOM PACK BB12B96R7 1/4 SPECTRUM
• 00199150031603 - NA: 2025-07-18 CUSTOM PACK BB2R88R9 PUMP/TABL
• 00199150032457 - NA: 2025-07-18 CUSTOM PACK BB8L48R9 TABLE PK
• 00199150033430 - NA: 2025-07-18 CUSTOM PACK BB12E24R9 UNC GOLD PD
• 00199150033461 - NA: 2025-07-18 CUSTOM PACK BB12Q81R H/L 1/2 IN TU
• 00199150033546 - NA: 2025-07-18 CUSTOM PACK BB5N65R17 OSU E
• 00199150033553 - NA: 2025-07-18 CUSTOM PACK BB12Q62R NORTON HEALTH