CDI™ Shunt Sensor

Basic Information

• Brand Name: CDI™ Shunt Sensor
• Primary DI: 00699753160767
• Version / Model: CDI510H
• Company Name: Terumo Cardiovascular Systems Corporation
• Labeler DUNS: 177655466
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-06
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4a646dfb-f506-41d0-aa0c-5d1864b99a2a

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	870.4330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31715	Cardiopulmonary bypass system blood gas sensor	A sterile transducer used with a cardiopulmonary bypass system to detect and measure the partial pressure of gases in the blood being circulated by the system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50699753160762	GS1	20 Piece Case	20	In Commercial Distribution
Primary	00699753160767	GS1

Premarket Submissions

Submission Number	Supplement Number
K133658	000