CODMAN® BACTISEAL®

Basic Information

• Brand Name: CODMAN® BACTISEAL®
• Primary DI: 10381780524083
• Version / Model: NS0343
• Catalog Number: NS0343
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-01
• Public Version: 4
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: 5b6b9644-b494-42c1-9068-3d9cba084aca

Device Description

CODMAN® BACTISEAL® Programmable Cylindrical Valve with Rickham Reservoir and Unitized SIPHONGUARD' Device and Distal Catheter Programmable in steps of 10mnm H2O (98 Pa) 30mm H2O to 200mm H2O (294Pa. 1900Pa) Includes 120cm Distal Length including SIPHONGUA

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: Yes
• 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
61376	Intracerebral infusion/drainage catheter, long-term	A sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780524083	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090348	000

Device Sizes

Type	Value	Unit	Text
Length	23	Centimeter

Storage Conditions

• 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
• Type: Storage Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius