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Total Vitals

FDA UDI

Class II (US FDA UDI)

by GlobalMed Holdings, LLC

Identity

Trade Name
Total Vitals FDA UDI
Generic Name
Multiple physiological parameter spot-check system, clinical FDA UDI
Device Name
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). FDA UDI
Model / Reference
USB FDA UDI
Description
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). FDA UDI

Identifiers

Catalog Number
GMR50700010 FDA UDI
Primary DI / UDI-DI
00850033167146 FDA UDI
510(k) Number
K170047 FDA UDI
FDA Product Code
MWI FDA UDI
DXN FDA UDI
FLL FDA UDI
NBW FDA UDI
DSH FDA UDI
DQA FDA UDI
GMDN Term
Multiple physiological parameter spot-check system, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
870.1130 FDA UDI
880.2910 FDA UDI
862.1345 FDA UDI
870.2800 FDA UDI
870.2700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple physiological parameter spot-check system, clinical

Total Vitals by GlobalMed Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple physiological parameter spot-check system, clinical.

Cleared under the same submission

K170047 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GlobalMed Holdings, LLC

Sources (1)

  • FDA UDI 6fc2b113-5424-4b05-92d6-955c2566f28e 35 fields · synced Jun 9, 2026