Surge Cardiovascular

Basic Information

• Brand Name: Surge Cardiovascular
• Primary DI: 00817278012235
• Version / Model: LVV-020S
• Catalog Number: LVV-020S
• Company Name: Med Michigan Holdings, LLC
• Labeler DUNS: 097462979
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-27
• Public Version: 5
• Public Version Date: 2022-09-21
• Public Version Status: Update
• Public Device Record Key: a57c7144-ff1d-491a-b4e7-4888c7088bc6

Device Description

PEAK Left Ventricular Vent Cannula, 20 Fr

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: 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
47533	Implantable ventricular circulatory assist system	A portable assembly of devices intended to provide mechanical assistance to a heart ventricle(s), typically by pumping blood from the left ventricle to the aorta through an extra-cardiac circuit. It includes an implantable pump(s), connecting cannula/graft(s), a percutaneous lead, and external components (e.g., battery pack, controller). It is typically intended to be used as a bridge to heart transplantation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10817278012232	GS1	Case	20	In Commercial Distribution
Primary	00817278012235	GS1