MYOtherm XP

GUDID 50613994010327

DELIVERY LINE 61399401032 4PK MYOTHERMXP

MEDTRONIC, INC.

Cardioplegia solution administration kit

• Primary Device ID: 50613994010327
• NIH Device Record Key: 0c107ed6-f105-4645-9c34-c7d2fae5cecf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MYOtherm XP
• Version Model Number: 61399401032
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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	30613994010323 [Primary]
GS1	50613994010327 [Package]; Contains: 30613994010323; Package: PK [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971105

FDA Product Code

• DTN: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-17

Devices Manufactured by MEDTRONIC, INC.

• 00763000764234 - NA: 2026-04-01 CUSTOM PACK CB11Z66R 1/4 LOOP
• 00763000764241 - NA: 2026-04-01 CUSTOM PACK CB11Z68R CDI PACK
• 00763000764319 - NA: 2026-04-01 CUSTOM PACK HY2G71R9 ST. AGNES PK
• 00763000764951 - NA: 2026-04-01 CUSTOM PACK BB12A73R AV LOOP
• 00763000770419 - NA: 2026-04-01 CUSTOM PACK 11Z79R1 VALVE SK LN
• 00763000770433 - NA: 2026-04-01 CUSTOM PACK BB12B18R HIIT FUS
• 00763000774127 - NA: 2026-04-01 CUSTOM PACK BB11U49R3 ADULT QUANTUM
• 00763000791421 - NA: 2026-04-01 CUSTOM PACK BB11Y57R5 HEART LUNG