MC3

Basic Information

• Brand Name: MC3
• Primary DI: 10854916006567
• Version / Model: 5798
• Catalog Number: 5798
• Company Name: MICHIGAN CRITICAL CARE CONSULTANTS, INC.
• Labeler DUNS: 806687406
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-10
• Public Version: 4
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 892c37a0-f453-4c7f-83bf-3627dfb3e4e7

Device Description

Soft Flow Aortic 21 FR 7MM STRAIGHT BULB VENTED

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: No
• 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
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
Previous	10854916006185	GS1
Package	20854916006571	GS1		10	In Commercial Distribution
Primary	10854916006567	GS1

Premarket Submissions

Submission Number	Supplement Number
K132451	000