Exodus

Basic Information

• Brand Name: Exodus
• Primary DI: H965100320
• Version / Model: 10032
• Company Name: NAVILYST MEDICAL, INC.
• Labeler DUNS: 809699023
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-14
• Public Version: 4
• Public Version Date: 2022-03-08
• Public Version Status: Update
• Public Device Record Key: 871f6845-ab6b-436f-8c6a-f35fff9fde30
• Distribution End Date: 2021-08-12

Device Description

10F x 35cm Standard Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating

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
GBO	CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4200	1
FGE	CATHETER, BILIARY, DIAGNOSTIC	Gastroenterology, Urology	876.5010	2
LJE	CATHETER, NEPHROSTOMY	Unknown		U
GBX	CATHETER, IRRIGATION	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11305	Closed-wound drain, non-bioabsorbable	A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H965100321	HIBCC	BOX	5	Not in Commercial Distribution	2021-08-12
Primary	H965100320	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	35	Centimeter
Catheter Gauge	10	French
Outer Diameter	3.4	Millimeter