GOODWIN HEART LINE

Basic Information

• Brand Name: GOODWIN HEART LINE
• Primary DI: B0664110090000
• Version / Model: 411009-000
• Catalog Number: 411009-000
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-05
• Public Version: 2
• Public Version Date: 2023-07-07
• Public Version Status: Update
• Public Device Record Key: 96c989ef-db06-4114-b643-fabf27d1677b

Device Description

A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during cardiopulmonary bypass procedure by connecting and administration line. 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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	870.4240	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
Package	B0664110090003	HIBCC	Case	10	In Commercial Distribution
Primary	B0664110090000	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K802545	000