ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00198506060120
• Version / Model: TVN-1434B
• Catalog Number: TVN-1434B
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-23
• Public Version: 1
• Public Version Date: 2024-07-31
• Public Version Status: New
• Public Device Record Key: 599fc7be-e24a-4f80-831d-5ce9b1cf8ead

Device Description

TITUS VENOCLYSIS NEEDLE, LUER LOCK, 14 GA., BLUNT NEEDLE, 34MM WORKING LENGTH, 3.66MM O.D RETENTION BEAD, 3MM IN LENGTH, 5.75MM FROM THE DISTAL END OF THE NEEDLE, 52.60MM OAL

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCD	Cannula, Ventricular	Neurology	882.4060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37462	Body aspiration needle, reusable	A sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00198506060120	GS1

Customer Contacts

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