MGC Diganostics

GUDID B3688008100310

Ultima System CPX - 230V UPS

MEDICAL GRAPHICS CORPORATION

Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system

• Primary Device ID: B3688008100310
• NIH Device Record Key: 3e5839d6-82eb-478e-9708-fbcd74d1618f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGC Diganostics
• Version Model 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
HIBCC	B3688008100310 [Primary]

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: 2018-07-19
• Device Publish Date: 2018-06-18

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