Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir

GUDID 50699753450108

Terumo Cardiovascular Systems Corporation

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator

• Primary Device ID: 50699753450108
• NIH Device Record Key: 1f52dd51-b7e9-4c39-b778-2a1dc0c65eb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir
• Version Model Number: 3CX*RX25RE
• 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	00699753450103 [Primary]
GS1	50699753450108 [Package]; Contains: 00699753450103; Package: 4 Piece Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130333

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: 2015-10-01

On-Brand Devices [Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir]

• 50699753450153: 3CX*RX15RE40
• 50699753450146: 3CX*RX15RW40
• 50699753450139: 3CX*RX15RE30
• 50699753450122: 3CX*RX15RW30
• 50699753450115: 3CX*RX25RW
• 50699753450108: 3CX*RX25RE