CDI® Blood Parameter Monitoring System 550 550AVHCT

GUDID 00886799001783

Monitor with two blood parameter modules and one H/S Probe.

Terumo Cardiovascular Systems Corporation

Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor

• Primary Device ID: 00886799001783
• NIH Device Record Key: 6d9bcc78-6882-4b27-a018-fa58703b2b62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CDI® Blood Parameter Monitoring System 550
• Version Model Number: 550AVHCT
• Catalog Number: 550AVHCT
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00886799001783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182110

FDA Product Code

• DRY: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-10
• Device Publish Date: 2018-11-09

On-Brand Devices [CDI® Blood Parameter Monitoring System 550]

• 00886799001790: Monitor with one blood parameter module and one H/S Probe.
• 00886799001783: Monitor with two blood parameter modules and one H/S Probe.