SYNERGY

GUDID 38033178241220

SORIN GROUP ITALIA SRL

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• Primary Device ID: 38033178241220
• NIH Device Record Key: 0c987069-22f1-4453-ad6c-8cb669784ae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNERGY
• Version Model Number: STD PTS PHISIO
• Company DUNS: 442126587
• Company Name: SORIN GROUP ITALIA SRL
• Device Count: 1
• 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: true
• 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	08033178241229 [Primary]
GS1	38033178241220 [Package]; Contains: 08033178241229; Package: TRAY [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032040

FDA Product Code

• KFM: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-12-08
• Device Publish Date: 2014-07-23

Devices Manufactured by SORIN GROUP ITALIA SRL

• 38033178018648 - Suction tip: 2024-04-12
• 38033178018655 - Suction tip: 2024-04-12
• 38033178018662 - Suction tip: 2024-04-12
• 38033178018679 - Suction tip: 2024-04-12
• 38033178018709 - Suction tip: 2024-04-12
• 38033178018716 - Suction tip: 2024-04-12
• 38033178018723 - Suction tip: 2024-04-12
• 38033178018730 - Suction tip: 2024-04-12