FDA.reportPublic FDA data

Direct Supply

Primary DI
18800003400567
Brand
Direct Supply
Company
Mediana.CO.LTD
Model
AVM-1
Catalog number
PA3DS-B0
Device description
The purpose and function of the Direct Supply Attendant Vital Signs Monitor AVM-1 is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate and temperature for adult patients in all hospital areas, and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics.
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051375000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051375000VITAL SIGNS MONITORMediana Co., Ltd.2005-07-28DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800003400567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1880000340056718800003400567

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
18800003400574Direct SupplyAVM-1PA3DS-PB02016-09-26

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Primary DI, Brand, Company table
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