Introducer Mini Kit/2

Basic Information

• Brand Name: Introducer Mini Kit/2
• Primary DI: 00886333213894
• Version / Model: 496217
• Catalog Number: 496217
• 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: 2016-09-09
• Public Version: 5
• Public Version Date: 2024-01-31
• Public Version Status: Update
• Public Device Record Key: cd093e79-8d1c-4430-a735-b61c59967ef9
• Distribution End Date: 2024-01-30

Device Description

7F Introducer Mini Kit/2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	870.1310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10886333213891	GS1	Box	10	Not in Commercial Distribution	2024-01-30
Primary	00886333213894	GS1
Package	20886333213898	GS1	Box	50	Not in Commercial Distribution	2024-01-30

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K780126	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			7F