FDA.reportPublic FDA data

RENPHO Blood Pressure Monitor

Primary DI
04897106770045
Brand
RENPHO Blood Pressure Monitor
Company
JOICOM CORPORATION
Model
RP-BPM001S
Published
2020-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K120058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120058000TRANSTEK BLOOD PRESSURE MONITORZhongshan Transtek Electronics Co., Ltd.2012-01-31DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04897106770045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04897106770045048971067700454897106770045

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous central venous pressure sensorA noninvasive, electronic device intended to transcutaneously detect a patient's central venous pressure (CVP) using light emission/diffusion signals (e.g., near-infrared spectroscopy). It consists of a small photoelectric unit placed on the jugular vein area of the neck, tubing for ambient pressure detection, and a calibration reference. The detected signals correlating to CVP are transmitted to a connected blood pressure monitor (not included) with integrated software for measurement, analysis, and display. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081060692
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810140063229Renpho RejuvenPUS-J-WTH012026-10-20
00810140063137FitindexF-MSC022026-08-18
00810140063144RENPHOR-MSC072026-08-18
00810140063151FitindexF-MSC032026-08-18
00810140063168RENPHOR-MSC082026-08-18
00810140062833RENPHOPUS-R-WTR01-BK2026-07-24
00810140063113RENPHOPUS-R-WMV01-BU2026-07-24
00810140063120RENPHOPUS-R-WTR10-BK2026-07-24
00810140063106Renpho Massage GunR-WMG042026-07-21
00810140063052RenphoR-HAP092026-06-23
00810140063069RenphoR-HAP102026-06-23
00810140063076RenphoR-G0062026-06-23
00810140063083RenphoR-L0012026-06-23
00810140063090RenphoSKB-24182026-06-23
00810140063045RENPHO Eye MassagerR-WME062026-05-26
00810140063014RENPHOPUS-R-WMV01-2-BK2026-05-08
00810140063021RENPHOPUS-R-WMG18-BK2026-05-08
00810140063038RENPHOPUS-R-WMG09-GY2026-05-08
00810140063007RENPHOPUS-R-MSC05-BK2026-04-20
00810140062994RENPHOPUS-R-MSC06-BK2026-04-08

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Primary DI, Brand, Company table
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00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
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06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
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