GUDID 00673978170114

MOTOR R95120-03 EXT DRIVE RECOND 540T

MEDTRONIC, INC.

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 00673978170114
• NIH Device Record Key: cfa56806-6f31-4af8-b103-050699214247
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: R95120-03
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978170114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941921

FDA Product Code

• DWA: Control, pump speed, cardiopulmonary bypass

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: 2015-06-19

Devices Manufactured by MEDTRONIC, INC.

• 00763000432973 - Vectris™: 2024-08-12 LEAD 977D160 TRIALING MRICS SBCMPCT EMAN
• 00763000432980 - Vectris™: 2024-08-12 LEAD 977D260 TRIALING MRICS COMPACT EMAN
• 00763000964603 - NA: 2024-08-12 CUSTOM PACK BB12H12R2 ADULT TABLE P
• 20763000967110 - NA: 2024-08-12 CUSTOM PACK BB12H25R 5PK 1/8 IN M/M
• 00763000967451 - NA: 2024-08-12 CUSTOM PACK BB12H59R UCHICAGOCPB3/8
• 00763000967482 - NA: 2024-08-12 CUSTOM PACK BB11M88R16 CARDIOHELP P
• 00763000946395 - DLP®: 2024-08-12 ADAPTER 10001 STRAIGHT 20PK 17L
• 00763000946517 - DLP®: 2024-08-12 CANNULA 70420 ART FLEX ARCH 20FR 20P 17L