Duet®

Basic Information

• Brand Name: Duet®
• Primary DI: 00613994445377
• Version / Model: 46914
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Labeler DUNS: 089055867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 47f9878f-35e9-48d3-b345-d9c6be0dda0d

Device Description

EDMS 46914 DUET BLUECORE SITES

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: MR Conditional
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWM	DEVICE, MONITORING, INTRACRANIAL PRESSURE	Neurology	882.1620	2
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61796	Cerebrospinal fluid external drainage kit	A collection of sterile devices intended to be used with an intracerebral or spinal infusion/drainage catheter (not included) to collect drained cerebrospinal fluid (CSF), and other fluids of similar physical characteristics, from the brain ventricles or from the lumbar subarachnoid (intrathecal) region as a means of reducing CSF volume and intracranial pressure (ICP). It typically includes devices such as a drip chamber, drainage bag, tubing set, catheter connector, stopcock, and filter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994445377	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K984053	000