MGC Diagnsotics 800810-031

GUDID 00810016250050

Ultima System CPX - 230 UPS

MEDICAL GRAPHICS CORPORATION

Cardiopulmonary stress exercise monitoring system

• Primary Device ID: 00810016250050
• NIH Device Record Key: 2c46d23b-6659-4022-8be4-a90aee61a77f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGC Diagnsotics
• Version Model Number: 800810-031
• Catalog Number: 800810-031
• Company DUNS: 094045622
• Company Name: MEDICAL GRAPHICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810016250050 [Primary]
HIBCC	B3688008100310 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061731

FDA Product Code

• BZL: Computer, Oxygen-Uptake

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-22

On-Brand Devices [MGC Diagnsotics]

• 00810016251125: GAS CO2 LINEARITY 3%CO2, BAL N2
• 00810016251118: GAS CO2 LINEARITY 5%CO2, BAL N2
• 00810016250623: GAS CO2 LINEARITY 21%O2, BAL N2
• 00810016250838: PREVENT FLOW SENSOR, 24 PACK
• 00810016250050: Ultima System CPX - 230 UPS