Capiox® Arterial Filter

GUDID 50699753450382

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system filter, arterial blood line

• Primary Device ID: 50699753450382
• NIH Device Record Key: 97d82e8b-31ad-49fa-afff-945c9e35b0bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capiox® Arterial Filter
• Version Model Number: CX*AF200X
• 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	00699753450387 [Primary]
GS1	50699753450382 [Package]; Contains: 00699753450387; Package: 10 Piece Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002026

FDA Product Code

• DTM: Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-14

Devices Manufactured by Terumo Cardiovascular Systems Corporation

• 50699753533924 - Cardiovascular Procedure Kit: 2025-01-20
• 50699753533955 - Cardiovascular Procedure Kit: 2025-01-20
• 50699753533962 - Cardiovascular Procedure Kit: 2025-01-20
• 00699753533936 - Cardiovascular Procedure Kit: 2025-01-17
• 00699753533943 - Cardiovascular Procedure Kit: 2025-01-17
• 00699753533882 - Cardiovascular Procedure Kit: 2025-01-16
• 50699753533894 - Cardiovascular Procedure Kit: 2025-01-16
• 00699753533905 - Cardiovascular Procedure Kit: 2025-01-16