FDA.reportPublic FDA data

VIVE

Primary DI
10810041980165
Brand
VIVE
Company
VIVE HEALTH LLC
Model
DMD1047
Device description
Blood Pressure Monitor for Smart Devices
Published
2019-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041980165PackageGS11In Commercial Distribution
00810041980168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198016510810041980165
00810041980168008100419801688100419801680810041980168

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-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 not designed to be portable and is typically used bedside.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810178883943ViveSUP3111BLK2026-03-06
00810178884506ViveMOB1141BLK322026-03-06
00810178884643ViveMOB1142BLK2026-03-06
00810178884766ViveMOB1144GRY2026-03-06
00810178884773ViveMOB1144BLU2026-03-06
00810178884780ViveMOB1144PNK2026-03-06
00810178885213ViveMOB1139BLK262026-03-06
00810178885220ViveMOB1139BLK282026-03-06
00810178885237ViveMOB1139BLK302026-03-06
00810178887040ViveLVA1004DBLU2026-03-06
00810178887057ViveLVA2030DBLU2026-03-06
00810178887392Vive MobilityMOB1079GRY2026-02-18
00810178886890ViveSUP2019BGEXS2026-02-17
00810178886906ViveSUP2019BGES2026-02-17
00810178886913ViveSUP2019BGEM2026-02-17
00810178886920ViveSUP2019BGEL2026-02-17
00810178886937ViveSUP2019BGEXL2026-02-17
00810178886944ViveSUP2019BLKXS2026-02-17
00810178886951ViveSUP2019BLKS2026-02-17
00810178886968ViveSUP2019BLKM2026-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850047516046Clovis AI RPMRemote Smart Health, LLCDXN2026-05-26
10850047516043Clovis AI RPMRemote Smart Health, LLCDXN2026-05-26
06920485308412PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-05-23
16942284601461SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601482SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601499SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601505SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601512SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601529SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601864SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
16942284601874SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
16942284601881SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601895SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
16942284601904SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601987SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
06951727602906MBUPAIShenzhen Changkun Technology Co., Ltd.DXN2026-03-24
26970392218445SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
06975164324436HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324535HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324542HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324610HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324627HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
00816042016356FORAFORA CARE INC.DXN2026-03-20
06953205995074Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995081Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995098Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995104Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995111Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995128Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995135Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20