FDA.reportPublic FDA data

Vive Precision

Primary DI
00810113577562
Brand
Vive Precision
Company
VIVE HEALTH LLC
Model
DMD1092BLK
Device description
Blood Pressure Monitor (Smart Phone Compatible)
Published
2024-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K220886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220886000Upper Arm Type Blood Pressure MonitorShenzhen Jamr Technology Co., Ltd.2022-07-27DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113577569PackageGS120In Commercial Distribution
00810113577562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357756910810113577569
00810113577562008101135775628101135775620810113577562

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.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810178889280CoreTechSUP3128BLKS2026-05-05
00810178889297CoreTechSUP3128BLKM2026-05-05
00810178889303CoreTechSUP3128BLKL2026-05-05
00810178889310CoreTechSUP3128BLKXL2026-05-05
00810178889327CoreTechSUP3128BLK2XL2026-05-05
00810226442306ViveDMD1087CUFF2026-08-25
00810226442245ViveCSH1116GRY2026-08-21
00810226442290ViveLVA3188BLK2026-08-21
00810178889648CoreTechSUP3156BLK2026-08-19
00810178889655ViveMOB1162BLK2026-08-19
00810178889662ViveMOB1162DBU2026-08-19
00810178889679ViveMOB1162TAL2026-08-19
00810226442016ViveLVA3187BLU422026-08-19
00810226442023ViveLVA3187BLU482026-08-19
00810226442030ViveLVA3187BLU542026-08-19
00810226441965ViveLVA3184BLK2026-08-14
00810226441972ViveLVA3184BLK2PAK2026-08-14
00810226441989ViveLVA3185BLK2026-08-14
00810178887743ViveRHB3076M2026-08-07
00810041980229ViveSUP1064TAL2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00093764604737A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
00093764604744A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
06953825911874AlphaMedShenzhen Urion Technology Co., LtdDXN2026-09-22
06953825911850sakerplusShenzhen Urion Technology Co., LtdDXN2026-09-18
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
00856324008778PARAMEDSILEX GLOBAL LLCDXN2026-08-22
06971522821753LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06971522821760LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06953825911805FOCUSED ADULT ADHD CLINICShenzhen Urion Technology Co., LtdDXN2026-08-19
09120073932778CNAP® ArmslingCNSystems Medizintechnik GmbHDXN2026-08-18
09120073932785CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932792CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932808CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932815CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932846CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932877CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
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
06953825911799SAKERShenzhen Urion Technology Co., LtdDXN2026-08-17
06920485308542BSXShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-14