FDA.reportPublic FDA data

Patient Monitor V10

Primary DI
18800003407757
Brand
Patient Monitor V10
Company
Mediana.CO.LTD
Model
V10
Catalog number
V10M-2PXNZU
Device description
The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.
Published
2019-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170497000V10Mediana Co., Ltd.2017-12-15DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800003407757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1880000340775718800003407757

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687879726
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800003455805Mediana Co., Ltd. Body Composition Analyzer I30I30M-XBXUS2023-08-23
08800003455928Mediana Co., Ltd. Body Composition Analyzer I20I20M-XBXUSI20M-XBXUS2023-08-23
08800003458301Mediana Co., Ltd. Body Composition Analyzer I25I25M-XBXUS2023-08-23
08800003458349Mediana Co., Ltd. Body Composition Analyzer I35I35M-XBXUS2023-08-23
08800003466115Mediana Co., Ltd. Body Composition Analyzer I35I35M-XBXNA2023-08-23
08800003466405Mediana Co., Ltd. Body Composition Analyzer I50I50M-XBXUS2023-08-23
08800003466412Mediana Co., Ltd. Body Composition Analyzer I55I55M-XBXUS2023-08-23
08800003467228Mediana Co., Ltd. Body Composition Analyzer I50I50M-XBXNA2023-08-23
08800003467235Mediana Co., Ltd. Body Composition Analyzer I55I55M-XBXNA2023-08-23
08800003468881Mediana Co., Ltd. Body Composition Analyzer I25I25M-XBXNA2023-08-23
08800003471508Mediana Co., Ltd. Body Composition Analyzer I30I30M-XBXNA2023-08-23
18800003465535Direct SupplyAVSM3AVSM3SNF-3XBNDU2021-06-23
18800003465528Direct SupplyAVSM3AVSM3SNF-3XBNEU2021-06-18
18800003460066Direct SupplyAVSM3AVSM3SNF-3XBNTU2020-12-17
18800003456847Direct SupplyAVSM2V10D-3XBNFU2020-06-24
18800003456809Direct SupplyAVSM2V10D-3XBCFU2020-03-06
18800003427205Patient Monitor M30M30M30M-1PXAH2019-08-08
18800003427847Patient Monitor M30M30M30M-3PXAH2019-08-08
18800003428929Patient Monitor M30M30M30M-5PNXAH2019-08-08
18800003400567Direct SupplyAVM-1PA3DS-B02016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06924054300623BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-06-04
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
06953825911041ELERAShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911188sakerplusShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911225AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911232AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
06976528061608Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06976528061615Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06931973410890CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-06-02
06932825303216TeleRPMGuangdong Transtek Medical Electronics Co.,LtdDXN2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DQA2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06920485308450BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DQA2026-06-01
06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06976528060335Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060342Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060359Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060366Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060373Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060380Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29