Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 10304040180263
• Version / Model: 5703713
• Catalog Number: 5703713
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2024-05-21
• Public Version: 1
• Public Version Date: 2024-05-29
• Public Version Status: New
• Public Device Record Key: 9bb6101d-48d5-48d0-88ae-1fe738106f5f

Device Description

Blood Control Safety IV Catheters are ergonomically designed with contoured catheter housing and a textured hub that creates a non-slip grip for easy handling. The Blood Control Safety IV Catheters feature a triple-facet, bevel needle with a fully encapsulating needle shield that encases the needle upon full retraction, providing safety without compromising functionality.

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18067	Intravenous line recessed-needle connector	A sterile device designed to allow access to either the Y-site of an intravenous (IV) line or an injection adaptor on the infusion catheter. Typically, a needle located inside a plastic housing can be inserted into a standard septum and a Luer fitting located at the opposite end allows the connection of a syringe or infusion set. A manual or automated mechanism moves the housing to protect the operator from the needle once the infusion is finished. The device is intended to eliminate an exposed needle after administration of medications. 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	00304040180266	GS1
Primary	10304040180263	GS1