CODMAN

Basic Information

• Brand Name: CODMAN
• Primary DI: 10886704000501
• Version / Model: 16-1057
• Catalog Number: 161057
• 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: 7
• Public Version Date: 2023-09-15
• Public Version Status: Update
• Public Device Record Key: 213f846e-3ce4-4450-983d-c71a7beba265
• Distribution End Date: 2022-09-01

Device Description

CODMAN Disposable ICP LUER-LOK Connector

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: 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
61118	Cerebrospinal fluid catheter tubing set	A two-way tubing with a stopcock designed to connect the proximal end of a cerebrospinal fluid (CSF) drainage catheter directly to a drainage bag or an intracranial pressure monitor via a Luer connection. It is typically made of polymer materials [e.g., polyvinyl chloride (PVC)] and profiled at both ends to create leak-proof connections. It may also feature a tap-like valve to isolate the line when injecting, flushing, or replacing the drainage bag. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886704000508	GS1	Package	3	Not in Commercial Distribution	2022-09-01
Primary	10886704000501	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K910938	000