Edwards Lifesciences Vascular Torniquet Kit

Basic Information

• Brand Name: Edwards Lifesciences Vascular Torniquet Kit
• Primary DI: 00690103041798
• Version / Model: TK2
• Catalog Number: TK2
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: 5465ea36-692c-482f-94d8-d1e43c214a87

Device Description

Vascular Torniquet Kit

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: 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
DXC	CLAMP, VASCULAR	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46852	Extraluminal vascular occluder, single-use	A device intended to be used to mechanically stop or interrupt the flow of blood in veins or arteries temporarily during vascular surgery and emergency trauma surgery. It is typically designed with a ring having a small portion left open so that it can be slipped over the blood vessel to be occluded, or it can have semicircular pivoted arms that can be opened and placed over the vessel with a latch to lock the arms once in place. The inner surface of this ring is lined with a soft-plastic balloon, or pair of balloons, inflated via a connecting tube using a standard syringe. This device facilitates occlusion with minimal trauma to the wall of the blood vessel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103041798	GS1
Unit of Use	70690103041797	GS1
Package	50690103041793	GS1	Shipper	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K910221	000