CODMAN ACCU-FLO

Basic Information

• Brand Name: CODMAN ACCU-FLO
• Primary DI: 10886704042181
• Version / Model: 82-6100
• Catalog Number: 826100
• 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: 5
• Public Version Date: 2023-09-15
• Public Version Status: Update
• Public Device Record Key: bef6d24c-17ef-4bb6-a9cc-a9a00c3b9c90
• Distribution End Date: 2022-09-01

Device Description

CODMAN ACCU-FLO 1 CSF Reservoir 14mm 1 Barium Ventricular Catheter, 1 Connector, Straight Barium Ventricular Catheter Connector, Straight 15cm

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: Yes
• 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
61375	Cranial port/reservoir	A sterile, implantable chamber intended to be connected to an intracerebral catheter for infusion/injection of materials (e.g., chemotherapeutic agents, radioisotopes) into the brain (e.g., cerebral ventricles, cystic tumours, tumour cavities); it may also be used for drainage of cerebrospinal fluid (CSF) from the ventricles and as part of a ventriculo-peritoneal/atrial shunt system. The device is implanted subcutaneously and materials infused/injected with a needle via hypodermic puncture flow into the target site through the connected catheter. It is typically a bulb-shaped device made of plastic material (e.g., polypropylene, silicone). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886704042181	GS1

Customer Contacts

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