Bio-Medicus™

Basic Information

• Brand Name: Bio-Medicus™
• Primary DI: 00763000116293
• Version / Model: 96820-108
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-09
• Public Version: 2
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 3551dd6f-84a8-4d31-b373-3bacbba20830

Device Description

CANNULA 96820-108 BIO-MED ART 8FR

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: No
• 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
34893	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial	A semi-rigid or rigid tube intended to be surgically inserted into an artery to serve as a channel for the extracorporeal transport of oxygenated blood to 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	00763000116293	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K143083	000

Device Sizes

Type	Value	Unit	Text
Length	22.9	Centimeter
Catheter Gauge	8.0	French