Ostial Sprit Cannulae

Basic Information

• Brand Name: Ostial Sprit Cannulae
• Primary DI: B270CVCP010080
• Version / Model: CV.CP01008
• Catalog Number: CV.CP01008
• Company Name: Spyder Medical
• Labeler DUNS: 035426132
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-02
• Public Version: 3
• Public Version Date: 2019-02-21
• Public Version Status: Update
• Public Device Record Key: 00f0d4a1-8b10-4118-bda7-d872840ce391

Device Description

Ostial Perfusion Cannula

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
34896	Vascular irrigation cannula, coronary artery, single-use	A sterile, rigid or semi-rigid tube designed to be surgically inserted, temporarily, into a coronary artery to serve as a channel for the transport of fluid during a surgical intervention. It is typically intended for the infusion and/or perfusion of fluids in diagnostic and/or surgical procedures, such as cardiopulmonary bypass, and to help avoid ischemia. Insertion is achieved with the use of a removable stylet or trocar blade. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B270CVCP010080	HIBCC
Package	B270CVCP010082	HIBCC		10	In Commercial Distribution
Package	B270CVCP010081	HIBCC		5	In Commercial Distribution