Surge Cardiovascular

Basic Information

• Brand Name: Surge Cardiovascular
• Primary DI: 00817278012365
• Version / Model: FEM-V1024
• Catalog Number: FEM-V1024
• Company Name: Med Michigan Holdings, LLC
• Labeler DUNS: 097462979
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-30
• Public Version: 4
• Public Version Date: 2022-09-21
• Public Version Status: Update
• Public Device Record Key: 95646bd9-7431-4079-ba23-a315f347735b

Device Description

ALPINE Femoral Venous Cannula, 24 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
34905	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous	A semi-rigid or rigid tube intended to be surgically inserted into the right atrium or large vein to serve as a channel for the extracorporeal transport of deoxygenated blood from a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817278012365	GS1
Package	00817278012617	GS1	Case	1	In Commercial Distribution