CODMAN HAKIM

Basic Information

• Brand Name: CODMAN HAKIM
• Primary DI: 10886704041863
• Version / Model: 82-3844
• Catalog Number: 823844
• Company Name: Cerenovus, Inc.
• Labeler DUNS: 607846297
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-20
• Public Version: 6
• Public Version Date: 2023-09-15
• Public Version Status: Update
• Public Device Record Key: 560989c7-50f3-4702-bccf-09d766e33731
• Distribution End Date: 2022-09-01

Device Description

CODMAN HAKIM Programmable Valve In-Line Valve and Unitized Distal Catheter Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) Includes: Programmable Valve, 14cm Ventricular Catheter, 120cm Peritoneal Catheter, Information Manual, Right Angle Adapter and Priming Adapter

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: Yes
• 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
45694	Ventriculoperitoneal shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to the peritoneal cavity, where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It typically consists of three main connected parts: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal catheter that channels the CSF to the peritoneal cavity. It is made of plastic and silicone materials; disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886704041863	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053107	000