PRIMO2X

GUDID 38033178100688

SORIN GROUP ITALIA SRL

Extracorporeal membrane oxygenator

• Primary Device ID: 38033178100688
• NIH Device Record Key: 367ea14d-a142-4014-90b3-f8969f13c271
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMO2X
• Version Model Number: PRIMO2X
• 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	08033178100687 [Primary]
GS1	38033178100688 [Package]; Contains: 08033178100687; Package: BOX [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050447

FDA Product Code

• DTZ: OXYGENATOR, 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: 2020-01-22
• Device Publish Date: 2015-07-15

On-Brand Devices [PRIMO2X]

• 38033178100718: PRIMO2X M
• 38033178100688: PRIMO2X