NA

Basic Information

• Brand Name: NA
• Primary DI: 00673978537474
• Version / Model: 1393
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b5462178-eff8-4877-be7e-2274d0b89759

Device Description

CONNECTOR 1393 HANSEN QUICK 90' ANGLE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWJ	SYSTEM, THERMAL REGULATING	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36374	Cardiopulmonary bypass system temperature control unit	An electronic device that is a module of a cardiopulmonary bypass system and that is used to measure and display the temperatures of the different temperature probes that are connected into the total system in order to monitor the fluid and blood temperatures at various points. It may also control the temperature levels, e.g., the temperature level of the fluid entering and leaving the heat exchanger.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673978537474	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K894980	000