MGC Diagnostics

Basic Information

• Brand Name: MGC Diagnostics
• Primary DI: B368800810001
• Version / Model: 800810-001
• Catalog Number: 800810-001
• Company Name: MEDICAL GRAPHICS CORPORATION
• Labeler DUNS: 094045622
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 4
• Public Version Date: 2021-08-10
• Public Version Status: Update
• Public Device Record Key: 75771217-a8e5-4a6e-967c-41b219c08fb3
• Distribution End Date: 2019-02-22

Device Description

Ultima System CPX

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZL	Computer, Oxygen-Uptake	Anesthesiology	868.1730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36146	Cardiopulmonary stress exercise monitoring system	An assembly of devices intended to noninvasively assess the cardiopulmonary response to exercise or measure of energy expenditure using indirect calorimetry. Breath by breath measurements of flow, oxygen (O2) uptake, and carbon dioxide (CO2) production are performed by O2 and CO2 analysers during exercise, along with the measurement of vital parameters. A mask, mouthpiece, or hood is attached to tubing and connected from the patient to the gas analysers while exercise is being performed using a particular device (e.g., an ergometer). The system typically monitors functions [e.g., provides continuous electrocardiogram (ECG)], provides control of the workload, and displays and prints results.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B368800810001	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K061731	000