CODMAN HAKIM SIPHONGUARD HOLTER

Basic Information

• Brand Name: CODMAN HAKIM SIPHONGUARD HOLTER
• Primary DI: 10886704041900
• Version / Model: 82-3854
• Catalog Number: 823854
• 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: eabfd9f9-3f2a-491d-849d-1f6c4fb1571f
• Distribution End Date: 2022-09-01

Device Description

CODMAN HAKIM Programmable Valve In-Line Valve SIPHONGUARD Device, .060 Inch Platform and Unitized Distal Catheter Operating Pressure: 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) programmable in steps of 10mm H2O (98 Pa) Includes: Ventricular Catheter 14cm, Stylet, Right Angle Adaptor, Straight Connector, HOLTER Type B Connector, Priming Adaptor and Information Manual

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
61123	Ventriculo-peritoneal/atrial shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to either the peritoneal cavity or the heart right atrium (i.e., dual-capability), where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It consists of: 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/atrial catheter that channels the CSF to the peritoneal cavity or right atrium; some types have a port/reservoir for hypodermic sampling/infusion. 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	10886704041900	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053350	000