FDA.reportPublic FDA data

Direct Supply

Primary DI
18800003465528
Brand
Direct Supply
Company
Mediana.CO.LTD
Model
AVSM3
Catalog number
AVSM3SNF-3XBNEU
Device description
The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure(NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation(SpO2), pulse rate (PR) and temperature (TEMP) 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 V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.
Published
2021-06-18
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
K200434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200434000V20, V20a, AVSM3 SNFMediana Co., Ltd.2020-10-09DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800003465528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1880000346552818800003465528

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose multi-parameter bedside monitorAn electrically-powered device/device assembly 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 set-up by the patient bedside and 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
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
18800003400574Direct SupplyAVM-1PA3DS-PB02016-09-26

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