FDA.reportPublic FDA data

Wellue/Viatom

Primary DI
06934440101017
Brand
Wellue/Viatom
Company
Shenzhen Viatom Technology Co.,Ltd.
Model
BP2A Blood Pressure Monitor
Published
2021-07-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
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
K193348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193348000Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd.2020-06-25DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934440101017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934440101017069344401010176934440101017

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421357243
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934440102021VIATOM Pulse OximeterPO22025-11-12
06934440102977LEPU MEDICALPO22025-03-17
06934440103066Pulse OximeterPO22025-03-17
06934440103073Pulse OximeterPO2A2025-03-17
06934440103080Pulse OximeterPO2B2025-03-17
06934440102311ViatomPO6 Oxyfit Pulse Oximeter2023-12-12
06934440102069CheckmeBP2 Blood Pressure Monitor2024-12-24
06934440102212Wellue/ViatomBP2 Blood Pressure Monitor2024-12-24
06934440102588LEPU MEDICALBP2 Blood Pressure Monitor2024-12-24
06934440102618BP2 Blood Pressure MonitorBP2 Blood Pressure Monitor2024-12-24
06934440102748CheckmeBP2A Blood Pressure Monitor2024-12-24
06934440102755BP2A Blood Pressure MonitorBP2A Blood Pressure Monitor2024-12-24
06934440102762LEPU MEDICALBP2A Blood Pressure Monitor2024-12-24
06934440102809Pulse OximeterS92024-12-23
06934440102816Pulse OximeterS102024-12-23
06934440102823Pulse OximeterS112024-12-23
06934440102830Pulse OximeterS122024-12-23
06934440102847Pulse OximeterS132024-12-23
06934440102854Pulse OximeterS13B2024-12-23
06934440102861Pulse OximeterS142024-12-23

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Primary DI, Brand, Company table
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00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
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06971522821760LineshareShenzhen Finicare Co., LtdDXN2026-08-22
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09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
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09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
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06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01