FDA.reportPublic FDA data

Total Vitals

Primary DI
00850033167146
Brand
Total Vitals
Company
Globalmed Holdings, LLC
Model
USB
Catalog number
GMR50700010
Device 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).
Published
2023-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter
DSHRecorder, Magnetic Tape, Medical
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLThermometer, Electronic, Clinical
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DSHRecorder, Magnetic Tape, MedicalCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063641000
K170047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063641000PC-60, NON-INVASIVEPULSE OXIMETERShenzhen Creative Industry Co., Ltd.2007-07-13DQA
K170047000All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.2017-09-09MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033167146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033167146008500331671468500331671460850033167146

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological parameter spot-check system, clinicalAn electrically-powered device assembly designed for professional use in a clinical setting to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2), blood glucose]; it has no continuous monitoring capability or programmable alarm features. It typically includes a main analysis unit with a visual display and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, SpO2 probe, spirometer), and potentially in vitro diagnostic [IVD] analysers (e.g., clinical chemistry analyser, urine analyser).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103201849
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085003316723ClinicalAccess® Kiosk1.01CAK0012025-06-26
00850033167221ClinicalAccess Pro Connect1.01CAP001-C01 / 1CAP001-C022025-06-26
00850033167184Smartest Persona II Multi Blood Glucose Monitoring System62762024-12-02
00850033167115eNcountereNcounter2023-12-12
00850033167108ClearStethGSW30100103GSW301001032023-12-08
00850033167122Variable Polarizing HoodGMD55100010GMD551000102023-12-08
00850033167139First Exam StationFirst Exam Station2023-12-08
00850033167153Total VitalsBluetoothGMR507000202023-12-08
00850033167160Total VitalsDual - BT & USBGMR507000302023-12-08
00850033167177Total ECGGMD50610001GMD506100012023-12-08
00850033167009TotalExam® 3.2 CameraGMD5504HD58GMD5504HD582023-08-04
00850033167016CAS Lite®1CSL0011CSL0012023-08-04
00850033167023TotalExam® Lite, 2.0 GMD5505HD21GMD5505HD212023-08-04
00850033167030TotalExam® Oto 2.0GMD5505HD22GMD5505HD222023-08-04
00850033167047TotalExam® Lite & Oto 2.0GMD5505HD20GMD5505HD202023-08-04
00850033167054Transportable Exam Station (TES)1TES0061TES0062023-08-04
00850033167061Clinical Access® Station (CAS)1CAS0041CAS0042023-08-04
00850033167078WallDoc®1WDC0031WDC0032023-08-04
00850033167085Next Exam Station (NES)GMR12150000GMR121500002023-08-04
00850033167092LiteExam® Station (LES)1LES0011LES0012023-08-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00682607551439ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
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00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
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