CODMAN BACTISEAL

Basic Information

• Brand Name: CODMAN BACTISEAL
• Primary DI: 10886704041337
• Version / Model: 82-3074
• Catalog Number: 823074
• 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: 8a8b1d8d-0406-478f-ab98-40baab73f7d3
• Distribution End Date: 2022-09-01

Device Description

CODMAN BACTISEAL Distal Catheter Kit with BACTISEAL Shunt System Contents: Distal Catheter 120cm (1), information manual (1)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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
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	10886704041337	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K102589	000

Storage Conditions

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