GENERATION II VALVED TEARWAY INTRODUCERGENERATION II VALVED TEARWAY INTRODUCER

Basic Information

• Brand Name: GENERATION II VALVED TEARWAY INTRODUCERGENERATION II VALVED TEARWAY INTRODUCER
• Primary DI: 00884908085747
• Version / Model: MR190703
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-27
• Public Version: 5
• Public Version Date: 2021-02-03
• Public Version Status: Update
• Public Device Record Key: 10792c0a-e91b-4ca5-9a94-087bce62cfeb
• Distribution End Date: 2021-01-29

Device Description

7F (2.4MM ID) X 12CM VALVED PEELABLE INTRODUCER

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: Yes
• 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: 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
DYB	INTRODUCER, CATHETER	Cardiovascular	870.1340	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	50884908085742	GS1	box	4	Not in Commercial Distribution	2021-01-29
Package	30884908085748	GS1	inner box	5	Not in Commercial Distribution	2021-01-29
Primary	00884908085747	GS1

Customer Contacts

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