S5 Mast Roller Pump

GUDID 04033817902744

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817902744
• NIH Device Record Key: 1e5c2d12-bec3-487c-8594-df6d2082d294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S5 Mast Roller Pump
• Version Model Number: Control Panel for 2 MRP85
• Company DUNS: 343225272
• Company Name: LivaNova Deutschland GmbH
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04033817902744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210130

FDA Product Code

• DTQ: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-24
• Device Publish Date: 2021-05-14

On-Brand Devices [S5 Mast Roller Pump]

• 04033817902775: S5 Min.I. Control Panel MRP85
• 04033817902768: S5 Min.I. Control Panel MRP150
• 04033817902744: Control Panel for 2 MRP85
• 04033817902720: Control Panel for 1 MRP
• 04033817900917: Color Coding Set
• 04033817900825: Control Panel for 2 MRP85
• 04033817900818: Control Panel for 1 MRP
• 04033817900481: MRP 85
• 04033817900474: MRP 150