Capiox® Hardshell Reservoir

GUDID 50699753450160

Terumo Cardiovascular Systems Corporation

Cardiotomy reservoir Cardiotomy reservoir

• Primary Device ID: 50699753450160
• NIH Device Record Key: b1575053-c761-40cc-9876-f6b078f66a59
• Commercial Distribution Discontinuation: 2018-12-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Capiox® Hardshell Reservoir
• Version Model Number: CX*SXRX
• 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	00699753450165 [Primary]
GS1	50699753450160 [Package]; Contains: 00699753450165; Package: 4 Piece Case [4 Units]; Discontinued: 2018-12-01; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130359

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: 2015-10-02

On-Brand Devices [Capiox® Hardshell Reservoir]

• 50699753450399: CX*CRXA
• 50699753450160: CX*SXRX