Cardiopulmonary bypass cannula holder set

Basic Information

• Brand Name: Cardiopulmonary bypass cannula holder set
• Primary DI: 00803622106101
• Version / Model: TS-xxxxx
• Company Name: LIVANOVA USA, INC.
• Labeler DUNS: 080914995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-16
• Public Version: 4
• Public Version Date: 2018-08-15
• Public Version Status: Update
• Public Device Record Key: 055c30ed-fde5-4f7a-bc92-af4fc52e685a

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
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	Cardiovascular	870.4210	2

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	10803622106108	GS1	CASE	20	In Commercial Distribution
Primary	00803622106101	GS1

Premarket Submissions

Submission Number	Supplement Number
K000830	000