CODMAN HAKIM BACTISEAL

Basic Information

• Brand Name: CODMAN HAKIM BACTISEAL
• Primary DI: 10886704048060
• Version / Model: NS5458
• Catalog Number: NS5458
• 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: 8
• Public Version Date: 2023-09-15
• Public Version Status: Update
• Public Device Record Key: 86ba81be-1acc-40f9-ab63-a16aeaaaa4ce
• Distribution End Date: 2022-09-01

Device Description

CODMAN HAKIM Precision Fixed Pressure Valve with Unitized Prechamber and BACTISEAL Catheters Operating Pressure: 100mm H2O Medium High Range Includes: BACTISEAL Ventricular Catheter 14cm, Stylet, Unitized BACTISEAL Peritoneal Catheter 120cm, Right Angle Adapter, Priming Adapter and Information Manual

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: 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	10886704048060	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091346	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 36 – 81 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 36 – 81 Degrees Fahrenheit