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
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
00810140062895RENPHOPUS-R-WMF01-WH2026-01-04
00810140062901RENPHOPUS-R-A018-BU-B12026-01-04
10810140062892RENPHOPUS-R-WMF01-WH2026-01-04
10810140062908RENPHOPUS-R-A018-BU-B12026-01-04
00810140062864RENPHOPUS-R-WMF08-BU2025-12-16
10810140062861RENPHOPUS-R-WMF08-BU2025-12-16
00810140062857RENPHOR-WMG242025-12-03
10810140062854RENPHOR-WMG242025-12-03
00810140062840RENPHOR-MSB042025-11-25
10810140062847RENPHOR-MSB042025-11-25
00810140062123RENPHOR-WMG102024-10-16
00810140062826RENPHOPUS-R-WMF09-BK2025-11-05
00810140062819RENPHOES-CS20M2025-10-24
00810140062802RENPHO Massage GunR-WMG152025-10-22

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Primary DI, Brand, Company table
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