GUDID 00673978170626

HANDCRANK R95183-01 RECON FA 150

MEDTRONIC, INC.

Centrifugal circulatory assist pump, manual

• Primary Device ID: 00673978170626
• NIH Device Record Key: 9421d8c1-a0d8-4310-83c0-ee688ee94850
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: R95183-01
• 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	00673978170626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926357

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.

• 00199150061679 - NA: 2026-01-29 CUSTOM PACK BB12S73R HLN 3LF
• 20613994654063 - DLP®: 2026-01-29 PCP SET 50011 5FR - 14GA 10PK 17L
• 00199150027521 - Cardioblate™: 2026-01-26 CLAMP 49321 CARDIOBLATE BP2 FT
• 00199150027538 - Cardioblate™: 2026-01-26 CLAMP 49341 CARDIOBLATE LP FT
• 00199150027569 - Cardioblate™: 2026-01-26 CARDIOBLATE 60831 BP2 DEVICE EN
• 00199150027576 - Cardioblate®: 2026-01-26 CARDIOBLATE 60841 LP STANDALONE EN
• 00763000999414 - SYNCHROMED™ III: 2026-01-23 PUMP 8667-20 SYNCHROMEDIII EMAN
• 00763000999421 - SYNCHROMED™ III: 2026-01-23 PUMP 8667-40 SYNCHROMEDIII EMAN