S5 Double Roller Pump 85

GUDID 04033817900443

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type

• Primary Device ID: 04033817900443
• NIH Device Record Key: 9ad355f1-fef5-40c8-b28a-02914b06412e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S5 Double Roller Pump 85
• Version Model Number: Inserts 5/16" x 3/32"
• 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: false
• 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	04033817900443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071318

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-05-07
• Device Publish Date: 2015-10-16

On-Brand Devices [S5 Double Roller Pump 85]

• 04033817902737: DRP 85
• 04033817900467: Inserts 3/32" x 1/16"
• 04033817900450: Inserts 3/16" x 1/16"
• 04033817900443: Inserts 5/16" x 3/32"
• 04033817900436: Inserts 1/4" x 3/32"
• 04033817900429: Inserts 1/4" x 1/16"
• 04033817900412: Inserts 1/8" x 1/16"
• 04033817900405: DRP 85