FDA.reportPublic FDA data

Patient Monitor

Primary DI
06938368100381
Brand
Patient Monitor
Company
General Meditech. Inc.
Model
G3N
Published
2024-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092970000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092970000GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.2010-02-02MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938368100381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938368100381069383681003816938368100381

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac arrhythmia monitoring systemAn assembly of devices comprised of modules or components (e.g., monitors, recorders, amplifiers) intended to be used to continually detect, measure, and display the electrical activity of the heart and to produce a visible or audible signal/alarm when an atrial or ventricular arrhythmia, such as a premature contraction or ventricular fibrillation, exists.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545261786
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938368100336Patient MonitorG3C2024-09-03
06938368100343Patient MonitorG3D2024-09-03
06938368100350Patient MonitorG3G2024-09-03
06938368100367Patient MonitorG3H2024-09-03
06938368100374Patient MonitorG3L2024-09-03
06938368100398Patient MonitorG3M2024-09-03
06938368100404Patient MonitorG3S2024-09-03
06938368100428Patient MonitorG2A2024-09-03
06938368113022Pulse OximeterG1B Plus2024-09-03
06938368100084Patient MonitorG3F2016-12-19
06938368100411Pulse OximeterG1B2024-08-27
06938368100022OximeterG1B Plus2016-12-19
06938368100046Patient MonitorG3C2016-12-19
06938368100060Patient MonitorG3D2016-12-19
06938368100107Patient MonitorG3G2016-12-19
06938368100121Patient MonitorG3H2016-12-19
06938368100145Patient MonitorG3L2016-12-19
06938368100169Patient MonitorG3N2016-12-19
06938368100183Patient MonitorG3M2016-12-19
06938368100206Patient MonitorG3S2016-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953205716CARESCAPE Telemetry ServerGe Medical Systems Information Technologies, Inc.MHX2026-06-05
00884838119017Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119024Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119031Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119048Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119055Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119062Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119185Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119192Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119208Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B353UB25501UbiqVue MultiparameterLifesignals, Inc.MHX2024-11-29
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMHX2024-06-07
B353UA2550BG1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550C1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550MR1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550RB1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550S1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550R1UbiqVue Lifesignals, Inc.MHX2024-05-06
B353UB15501UbiqVue MultiparameterLifesignals, Inc.MHX2024-05-06
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00382830062954Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062961Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062985Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
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00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14