Surge Cardiovascular

Basic Information

• Brand Name: Surge Cardiovascular
• Primary DI: 00817278011306
• Version / Model: TOU-7904
• Catalog Number: TOU-7904
• Company Name: Alliant Enterprises, LLC
• Labeler DUNS: 121170653
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: acadef74-fad8-4fd3-879f-fab17d065459
• Distribution End Date: 2017-07-31

Device Description

Adult Tourniquet Kit with Snare, 1 red, 1 blue, 7" length, non-sterile

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58830	Cardiopulmonary bypass cannula holder set	A collection of sterile devices intended to help secure a cardiopulmonary bypass cannula to the underlying tissue in the operative field to minimize displacement of the cannula during cardiopulmonary bypass surgery. Popularly known as a `snugger?, it typically consists of a number of colour-coded plastic tubes which can be cut to length, and a metal wire snare. The snare is intended to grasp a purse-string suture and to pull it taut through the tube; a holding suture is tied around the tube and the cannula to keep the cannula in place. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817278011300	GS1	Case	4	Not in Commercial Distribution	2017-07-31
Package	10817278011303	GS1	Inner Bag	25	Not in Commercial Distribution	2017-07-31
Primary	00817278011306	GS1