Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.

GUDID 50699753450450

Terumo Cardiovascular Systems Corporation

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator

• Primary Device ID: 50699753450450
• NIH Device Record Key: d5d442c8-ada9-4053-a60c-ea3bc1425e1d
• Commercial Distribution Discontinuation: 2018-12-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.
• Version Model Number: 3CX*FX15RE40
• 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	00699753450455 [Primary]
GS1	50699753450450 [Package]; Contains: 00699753450455; Package: 4 Piece Case [4 Units]; Discontinued: 2018-12-01; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140774

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: 5
• Public Version Date: 2020-01-22
• Device Publish Date: 2015-10-01

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

• 50699753450757: 3CX*FX15RW40
• 00699753450745: 3CX*FX15RW30
• 50699753450474: 3CX*FX25RW
• 50699753450467: 3CX*FX25RE
• 50699753450450: 3CX*FX15RE40
• 50699753450443: 3CX*FX15RE30