Cournand-Style Needle

Basic Information

• Brand Name: Cournand-Style Needle
• Primary DI: 00886333208487
• Version / Model: 195336
• Catalog Number: 195336
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-10
• Public Version: 4
• Public Version Date: 2024-01-30
• Public Version Status: Update
• Public Device Record Key: 77298903-9ae8-4079-9417-c02751e356aa
• Distribution End Date: 2024-01-29

Device Description

Cournand-Style Needle – 18ga x 2.125" (5.4cm)

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
DRC	Trocar	Cardiovascular	870.1390	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	10886333208484	GS1	Box	10	Not in Commercial Distribution	2024-01-29
Primary	00886333208487	GS1
Package	20886333208481	GS1	Box	150	Not in Commercial Distribution	2024-01-29

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K772369	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			18ga x 2.125” (5.4cm)