GENERATION II VALVED TEARAWAY INTRODUCERGENERATION II VALVED TEARAWAY INTRODUCER

Basic Information

• Brand Name: GENERATION II VALVED TEARAWAY INTRODUCERGENERATION II VALVED TEARAWAY INTRODUCER
• Primary DI: 00884908143409
• Version / Model: DMR191103
• Catalog Number: DMR191103
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-12
• Public Version: 1
• Public Version Date: 2019-07-22
• Public Version Status: New
• Public Device Record Key: d82e8a8a-c690-440d-ab28-4e39d63504a1

Device Description

11F (3.7MM ID) X 12CM11F (3.7MM VALVED PEELABLE INTRODUCERVALVED

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	30884908143400	GS1	inner box	5	In Commercial Distribution
Primary	00884908143409	GS1
Package	50884908143404	GS1	box	4	In Commercial Distribution

Customer Contacts

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