6ml Syringe, NFV x SCD

Basic Information

• Brand Name: 6ml Syringe, NFV x SCD
• Primary DI: 10816203020229
• Version / Model: RV-T15
• Company Name: ORIGEN BIOMEDICAL, INC.
• Labeler DUNS: 625272232
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: 06e17827-00b9-4c0a-be72-bf712bbdfbd9

Device Description

6ml syringe on a needle-free valve with 15cm SCD tubing with porous vent plug , case of 25

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: 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
KJG	Tube, Tissue Culture	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43324	Fluid transfer set, general-purpose	A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10816203020229	GS1
Package	20816203020226	GS1	Case	25	In Commercial Distribution