FDA.reportPublic FDA data

TotalVitals

Primary DI
B377GMDTVSBPO2T0
Brand
TotalVitals
Company
Globalmed Holdings, LLC
Model
N/A
Catalog number
GMDTVSBPO2T
Published
2016-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123711000PATIENT MONITORShenzhen Creative Industry Co., Ltd.2013-10-01MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B377GMDTVSBPO2T0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological parameter spot-check analysis system, clinicalAn electrically-powered device assembly, possibly with a rechargeable battery, designed to electronically measure and display multiple patient physiological parameters [e.g., noninvasive blood pressure (NIBP), pulse rate, temperature, and haemoglobin oxygen saturation (SpO2)] for intermittent spot-check measuring by a healthcare professional; 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). It may be attached to a wheeled stand or wall-mounted.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103201849
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B377GMD306100XXX0eNcounterCloud2.3.x.x2016-10-06
B377GMR1602008X0CapSure Cloud2.1.x2016-09-12
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
00850033167146Total VitalsUSBGMR507000102023-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725547168APKAPK Technology Co.,Ltd.DQA2026-09-24
06946725571705APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725571903APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06924054300920BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880031UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
00840118620987Endure IndustriesENDURE INDUSTRIESDQA2026-08-14
06946725572078APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572085APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572092APKAPK Technology Co.,Ltd.DQA2026-08-14
06924054300906BERRYSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-07-30
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09