Total Vitals GMR50700010

GUDID 00850033167146

The All-in-One Health Monitor is a device designed for measuring the patient’s physiological parameters, such as Non-Invasive Blood Pressure (NIBP), Oxygen saturation (SpO2), Pulse Rate (PR) and Body Temperature (TEMP).

GLOBALMEDIA GROUP, LLC

Multiple physiological parameter spot-check system, clinical

• Primary Device ID: 00850033167146
• NIH Device Record Key: 6fc2b113-5424-4b05-92d6-955c2566f28e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Vitals
• Version Model Number: USB
• Catalog Number: GMR50700010
• Company DUNS: 103201849
• Company Name: GLOBALMEDIA GROUP, LLC
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	00850033167146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063641

FDA Product Code

• DQA: Oximeter

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: 2023-12-18
• Device Publish Date: 2023-12-08

On-Brand Devices [Total Vitals]

• 00850033167160: The All-in-One Health Monitor is a device designed for measuring the patient’s physiological p
• 00850033167153: The All-in-One Health Monitor is a device designed for measuring the patient’s physiological p
• 00850033167146: The All-in-One Health Monitor is a device designed for measuring the patient’s physiological p