Navi Needle-free Blood Collection Device

Basic Information

• Brand Name: Navi Needle-free Blood Collection Device
• Primary DI: 20850073657021
• Version / Model: VNC20500FG
• Company Name: Venocare, Inc.
• Labeler DUNS: 118792742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2026-01-20
• Public Version: 1
• Public Version Date: 2026-01-28
• Public Version Status: New
• Public Device Record Key: 402b5f21-13b8-4297-a0fb-8878c71d8e8c

Device Description

Navi Needle-free Blood Collection Device, 20GA Compatible with 20GA Peripheral IV Catheter

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
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44903	Blood transfer set	A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850073657027	GS1
Primary	20850073657021	GS1

Premarket Submissions

Submission Number	Supplement Number
K244047	000