PERFUSION ADAPTER SET, .165 X .230, 10"

Basic Information

• Brand Name: PERFUSION ADAPTER SET, .165 X .230, 10"
• Primary DI: B066301021NS1
• Version / Model: 301021NS
• Catalog Number: 301021NS
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2015-10-09
• Public Version: 3
• Public Version Date: 2023-07-14
• Public Version Status: Update
• Public Device Record Key: 7ba6f1db-2114-415c-830b-3f615fca9d9c

Device Description

A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.

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: 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
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58824	Cardioplegia solution administration adaptor	A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B066301021NS1	HIBCC
Unit of Use	B06630121NS0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K801403	000