Capiox® iCP Centrifugal Pump

GUDID 50699753450962

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 50699753450962
• NIH Device Record Key: 2036eb70-641f-4e97-ac10-452b85b1fcad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capiox® iCP Centrifugal Pump
• Version Model Number: 3CX*CP8
• 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	00699753450967 [Primary]
GS1	50699753450962 [Package]; Contains: 00699753450967; Package: 8 Piece Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200091

FDA Product Code

• KFM: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-17

On-Brand Devices [Capiox® iCP Centrifugal Pump]

• 50699753450979: 3CX*CP8J
• 50699753450962: 3CX*CP8