FDA.reportPublic FDA data

Tenovi

Primary DI
G004TCBPML20
Brand
Tenovi
Company
Tenovi Co.
Model
TC-BPM-L2
Device description
Tenovi Bluetooth Blood Pressure Monitor - Large Cuff Size
Published
2023-06-20
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G004TCBPML20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Telemetric sphygmomanometerAn electrically-powered device designed to noninvasively measure blood pressure by automatically inflating and deflating a cuff that typically fits around a limb (arm or thigh); it may in addition measure the heart rate and mean arterial pressure. It typically incorporates a display and controls, and may include a blood pressure cuff with connection tubing. The measurements can be wirelessly sent to a medical facility for analysis, typically using a computer or mobile phone with a dedicated software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
127061577
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850068074204TenoviTE-CBPS-B12026-04-14
00850068074563TenoviTE-BBPH-B12026-04-14
00850068074082TenoviTE-CPOG-A12026-01-14
00860008115997TenoviTE-BBPL-A12026-01-14
00850068074105TenoviTE-BPOG-A12026-01-07
00850068074402TenoviTE-BBPL-C12026-01-05
00850068074174TenoviTE-KBGZ-A12026-01-02
00850068074181TenoviTE-CBPL-B12026-01-02
00850068074211TenoviTE-CBPH-B12026-01-02
00850068074228TenoviTE-KPBG-A22026-01-02
00850068074266TenoviTE-CBGZ-A12026-01-02
00850068074365TenoviTE-BBPS-B12026-01-02
00850068074518TenoviTE-BFDG-A12025-11-24
00850068074310TenoviTE-BSCW-A12025-11-20
00850068074389TenoviTE-CSCW-A12025-11-20
00850068074457TenoviTE-BBGZ-B12025-11-20
00850068074471TenoviTE-BSCR-B12025-11-20
00085006807402TenoviTE-BPBG-A12025-08-29
00850068074020TenoviTE-BPBG-A12025-09-08
00850068074006TenoviTE-BTMI-A12025-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850070979405FondCircleFondCircle Inc.DXN2026-10-21
00850070979412FondCircleFondCircle Inc.DXN2026-10-21
08719327007136FinapresFinapres Medical Systems B.V.DXN2026-10-21
06953825911942CofoeShenzhen Urion Technology Co., LtdDXN2026-10-20
06953825911928CofoeShenzhen Urion Technology Co., LtdDXN2026-10-19
06953825911904saidianShenzhen Urion Technology Co., LtdDXN2026-10-14
06974560230655ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-14
06953825911881N/AShenzhen Urion Technology Co., LtdDXN2026-10-13
06974560230648ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-13
00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
06933257920187Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257926066YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257931688YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947016YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947023Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947030YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06973826012240AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012257AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012264AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012271AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012288AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012295AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012301AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012318AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012325AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012332AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012349AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012356AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09