Total Vitals GMR50700020

GUDID 00850033167153

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 ID00850033167153
NIH Device Record Key2287946e-dbe3-4299-8044-b6285c396a6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTotal Vitals
Version Model NumberBluetooth
Catalog NumberGMR50700020
Company DUNS103201849
Company NameGLOBALMEDIA GROUP, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033167153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-18
Device Publish Date2023-12-08

On-Brand Devices [Total Vitals]

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

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