FDA.reportPublic FDA data

iHealth

Primary DI
10856362005149
Brand
iHealth
Company
IHEALTH LAB INC.
Model
BP5S
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171062000BP5S Wireless Blood Pressure MonitorAndon Health Co, Ltd.2017-08-01DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856362005149PackageGS124In Commercial Distribution
00856362005142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085636200514910856362005149
00856362005142008563620051428563620051420856362005142

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive blood pressure physical simulatorAn instrument designed to mimic the pressure variations acting on the cuff of noninvasive arterial blood pressure monitoring/measuring devices when placed on a patient's arm. It typically simulates blood pressure values (e.g., systolic, diastolic, mean) and abnormal states (e.g, hypertensive, hypotensive). It usually consists of an internal pump to generate the testing pressures, manometers, electronic circuitry, and a display. The device is used to test oscillometric noninvasive blood pressure monitors and electronic sphygmomanometers as a complete set including the transducer; some may also be used to test auscultatory sphygmomanometers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054953337
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
10850044118691iHealthPT2L2025-12-19
10850044118707iHealthPT9L2025-12-19
10850044118721iHealthPT9L2025-12-19
10850044118776iHealthBG5S2025-12-19
10850044118806iHealthAG-6072025-12-19
10850078377088iHealthKN-550BT2025-12-19
10856362005156iHealthBG5SKIT2025-12-19
10856362005392iHealthKN-550BT2025-12-19
10850044118967iHealthBP-300CL2025-12-10
10850044118844iHealth3.6g*902024-11-18
10850044118868iHealthANC12024-10-30
10850044118783iHealthF50432024-09-28
10850044118233iHealthBG5SKIT2024-05-28
10850044118240iHealthBG5SKIT2024-05-27
10850044118424iHealthICF-30002024-05-25
10850044118431iHealthICF-30002024-05-24
10850044118455iHealthICF-30002024-05-24
10850044118257iHealthEGS-20032023-08-30
10850044118264iHealthEGS-20032023-08-30
10850044118202iHealthEGS-20032023-08-24

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