MICRO

GUDID 38033178114562

SORIN GROUP ITALIA SRL

Cardiopulmonary bypass system filter, arterial blood line

• Primary Device ID: 38033178114562
• NIH Device Record Key: debeb72f-25bf-41d4-9fd3-3ba396290c6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICRO
• Version Model Number: 40 µm Small Adult Arterial Filter
• 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: true
• 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	08033178114561 [Primary]
GS1	38033178114562 [Package]; Contains: 08033178114561; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242092

FDA Product Code

• DTM: Filter, blood, cardiopulmonary bypass, arterial line

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-12
• Device Publish Date: 2025-03-04

On-Brand Devices [MICRO]

• 38033178114609: 40 µm Infant Arterial Filter
• 38033178114579: 40 µm Adult Arterial Filter
• 38033178114562: 40 µm Small Adult Arterial Filter