CODMAN® BACTISEAL®

Basic Information

• Brand Name: CODMAN® BACTISEAL®
• Primary DI: 10381780525271
• Version / Model: NS5075
• Catalog Number: NS5075
• 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: 6
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: be08ae29-65b8-4468-8b7d-08fbd237e90b

Device Description

CODMAN® BACTISEAL® Catheters

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
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
61159	Peritoneal/atrial cerebrospinal fluid catheter	A flexible tube intended to be implanted as the distal component of a ventriculo-peritoneal/atrial shunt, to channel cerebrospinal fluid (CSF) to either the peritoneal cavity or the right atrium (i.e., dual-capability) where it can be absorbed into the body. It is intended to be part of a therapeutic measure for situations where excess CSF causes elevated intracranial pressure (hydrocephalus). 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	10381780525271	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K020667	000

Device Sizes

Type	Value	Unit	Text
Length	15	Centimeter

Storage Conditions

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