CDI™ H/S Cuvette 3/8 x 3/8

Basic Information

• Brand Name: CDI™ H/S Cuvette 3/8 x 3/8
• Primary DI: 00699753270152
• Version / Model: 6913
• 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: 89665398-5f8f-4d94-aea8-2142a945e5ff

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: No
• 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	50699753270157	GS1	6 Piece Case	6	In Commercial Distribution
Package	30699753270153	GS1	20 Piece Case	20	In Commercial Distribution
Primary	00699753270152	GS1

Premarket Submissions

Submission Number	Supplement Number
K133658	000