FDA.reportPublic FDA data

KARDIGI

Primary DI
06953825908669
Brand
KARDIGI
Company
Shenzhen Urion Technology Co., Ltd
Model
U80B
Published
2024-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
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
16953825908666PackageGS120In Commercial Distribution
06953825908669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695382590866616953825908666
06953825908669069538259086696953825908669

Regulatory Flags#

DUNS number
421294358
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
06953825908218beebirdU86Eyes2024-06-05
06953825909529SDUNWU80X2025-03-05
06953825909628AlphagoMedU807Yes2025-04-18
06953825905941N/AU80A2022-06-12
06953825911942CofoeU90B Pro2026-10-20
06953825911928CofoeU90B Pro2026-10-19
06953825911904saidianU19S2026-10-14
06953825911881N/AU86Y2026-10-13
06953825910501arboleafU90B2026-10-10
06953825911874AlphaMedU80EH2026-09-22
06953825911850sakerplusU90B2026-09-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970331860779blood pressure monitorShenzhen Ruiankang Technology Co. Ltd.DXN2026-11-04
06927709405452AmetmedShenzhen Jamr Technology Co., Ltd.DXN2026-11-03
00841709121746MidmarkMIDMARK CORPORATIONDXN2026-10-30
00841709121753MidmarkMIDMARK CORPORATIONDXN2026-10-30
00841709121760MidmarkMIDMARK CORPORATIONDXN2026-10-30
00841709121777MidmarkMIDMARK CORPORATIONDXN2026-10-30
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