VANGUARD

GUDID 38033178250628

SORIN GROUP ITALIA SRL

Cardioplegia solution administration kit

• Primary Device ID: 38033178250628
• NIH Device Record Key: d611fd0b-6f0d-49b9-889a-840255f6d68f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD
• Version Model Number: D928S BLOOD DELIVERY SET 8:1
• Company DUNS: 442126587
• Company Name: SORIN GROUP ITALIA SRL
• 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: 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	08033178250627 [Primary]
GS1	38033178250628 [Package]; Contains: 08033178250627; Package: BOX [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934847

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: 4
• Public Version Date: 2021-10-19
• Device Publish Date: 2015-07-10

On-Brand Devices [VANGUARD]

• 38033178250628: D928S BLOOD DELIVERY SET 8:1
• 38033178250611: D924P BLOOD DELIVERY SET 4:1
• 38033178250604: D924S BLOOD DELIVERY SET 4:1
• 38033178250598: D924 BLOOD DELIVERY SET 4:1
• 38033178250581: D921 BLOOD DELIVERY SET 1:1