Splittable Needle Introducer

Basic Information

• Brand Name: Splittable Needle Introducer
• Primary DI: 00886333209590
• Version / Model: 28 GA (1.2F) x 20 mm
• Catalog Number: 384061
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5453c4e0-ca4d-457b-b900-97481abe34e1

Device Description

Splittable Needle Introducer 28ga (1.2F) x 20mm

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: 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
LJS	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days	General Hospital	880.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61502	Vascular catheter introduction needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. Its lumen is not intended to be filled with an obturator/dilator and it does not include additional access devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886333209594	GS1	Box	10	In Commercial Distribution
Primary	00886333209590	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K920755	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			28 GA (1.2F) x 20 mm