FDA.reportPublic FDA data

carda health

Primary DI
06953825909307
Brand
carda health
Company
Shenzhen Urion Technology Co., Ltd
Model
U82W
Published
2025-01-10
Public version status
Update
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
K160019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160019000U80 Series Upper Arm Electronic Blood Pressure MonitorShenzhen Urion Technology Co., Ltd.2016-04-22DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16953825909304PackageGS140In Commercial Distribution
06953825909307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695382590930416953825909304
06953825909307069538259093076953825909307

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
421294358
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06953825911805FOCUSED ADULT ADHD CLINICU83Y2026-08-19
06953825911799SAKERU90B2026-08-17
06953825911690PianieyU87Z2026-08-01
06953825911706SAKERU90B2026-08-01
06953825911720N/AU16H2026-08-01
06953825911683SAKER UltraU90B2026-07-27
06953825911645N/AU90B Pro2026-07-24
06953825911652ANOVATORU8072026-07-24
06953825911669SPASTACISEU90B Pro2026-07-24
06953825911676N/AUM6052026-07-24
06953825911638ZKZOUFR1022026-07-23
06953825911515N/AU90B Pro2026-07-16
06953825911416N/AU86E2026-07-13
06953825911294N/AU16H2026-07-09
06953825911300N/AU82Z2026-07-09
06953825911317AlphamedU19M2026-07-09
06953825911355N/AU90B Pro2026-07-09
06953825911393N/AU16P2026-07-09
06953825911041ELERAU82V2026-06-03
06953825911188sakerplusU90B2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00057475244125BIOS DiagnosticsThermor LtdDXN2026-08-07
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911706SAKERShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01