NA

Basic Information

• Brand Name: NA
• Primary DI: 00643169472365
• Version / Model: 44515
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Labeler DUNS: 089055867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-10
• Public Version: 4
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 308df15f-9557-4b41-a3f3-87fac423148a

Device Description

RES 44515 CSF-LUMBOPERITONEAL 30MM

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61524	Cerebrospinal fluid shunt valve/port/reservoir	An implantable component of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt designed to regulate the pressure and/or flow of cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine or brain to the peritoneal cavity or heart right atrium in the management of raised CSF pressure (e.g., caused by hydrocephalus), and to permit hypodermic infusion/injection of materials into the central nervous system via the subarachnoid space; it may also be used for drainage of CSF. It consists of a subcutaneous puncturable dome with catheter connections, and a non-return and/or mechanical valve that typically opens at a pre-set pressure and may be non-invasively adjusted.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169472365	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K831396	000