BioFlo

Basic Information

• Brand Name: BioFlo
• Primary DI: H965103038050
• Version / Model: 03-805
• Company Name: NAVILYST MEDICAL, INC.
• Labeler DUNS: 809699023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-17
• Public Version: 4
• Public Version Date: 2021-05-05
• Public Version Status: Update
• Public Device Record Key: 22dc1fbe-5e9b-4ded-908a-a7fbeff57a56

Device Description

15.5Fx32cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit

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
MSD	Catheter, hemodialysis, implanted	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37278	Double-lumen haemodialysis catheter, implantable	An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H965103038051	HIBCC	BOX	5	In Commercial Distribution
Primary	H965103038050	HIBCC
Secondary	15051684025515	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	18	Gauge
Outer Diameter	5.2	Millimeter
Catheter Gauge	15.5	French
Length	32	Centimeter