BioFlo

Basic Information

• Brand Name: BioFlo
• Primary DI: H965460270
• Version / Model: 46-027
• Company Name: NAVILYST MEDICAL, INC.
• Labeler DUNS: 809699023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-04
• Public Version: 4
• Public Version Date: 2021-05-06
• Public Version Status: Update
• Public Device Record Key: 53cef7ed-5925-4a3f-a5bb-d18cfd79c2e7

Device Description

BioFlo Midline with ENDEXO Technology (4F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing 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
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days	General Hospital	880.5970	2
PND	Midline catheter	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36257	Peripherally-inserted central venous catheter	A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	H965460270	HIBCC
Package	H965460271	HIBCC	BOX	5	In Commercial Distribution
Secondary	15051684026994	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163452	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	4	French
Length	20	Centimeter
Outer Diameter	1.4	Millimeter
Needle Gauge	21	Gauge
Pressure	181	Pound per Square Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius