NX19 Oxygenator; left-side outlet port

GUDID 50699753450894

Terumo Cardiovascular Systems Corporation

Extracorporeal membrane oxygenator

• Primary Device ID: 50699753450894
• NIH Device Record Key: 3e535a78-9ed2-4e35-889d-31f91ca26e72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NX19 Oxygenator; left-side outlet port
• Version Model Number: 3CX*NX19W
• Company DUNS: 177655466
• Company Name: Terumo Cardiovascular Systems Corporation
• 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	00699753450899 [Primary]
GS1	50699753450894 [Package]; Contains: 00699753450899; Package: 4 Piece Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180950

FDA Product Code

• DTZ: Oxygenator, Cardiopulmonary Bypass

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: 2021-03-26
• Device Publish Date: 2021-03-18

On-Brand Devices [NX19 Oxygenator; left-side outlet port]

• 50699753450993: 3CX*NX19W
• 50699753450894: 3CX*NX19W