Capiox® iCP Centrifugal Pump

GUDID 50699753450979

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 50699753450979
• NIH Device Record Key: ad13323e-a6f6-48d8-bceb-257b68366850
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capiox® iCP Centrifugal Pump
• Version Model Number: 3CX*CP8J
• 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	00699753450974 [Primary]
GS1	50699753450979 [Package]; Contains: 00699753450974; 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