Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.

GUDID 50699753450801

Terumo Cardiovascular Systems Corporation

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator

• Primary Device ID: 50699753450801
• NIH Device Record Key: 8e54cd95-0ce6-44af-9306-fe7ef5b7815d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.
• Version Model Number: 3CX*FX15RE30C
• 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	00699753450806 [Primary]
GS1	50699753450801 [Package]; Contains: 00699753450806; Package: 4 Piece Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151389

FDA Product Code

• DTR: Heat-Exchanger, 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: 2016-01-20

On-Brand Devices [Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.]

• 50699753450832: 3CX*FX25RWC
• 50699753450825: 3CX*FX25REC
• 50699753450818: 3CX*FX15RE40C
• 50699753450801: 3CX*FX15RE30C
• 50699753450795: 3CX*FX15RW40C
• 50699753450788: 3CX*FX15RW30C