FDA.reportPublic FDA data

SCIAN

Primary DI
06970384254440
Brand
SCIAN
Company
HONSUN (NANTONG) CO.,LTD
Model
LD-562
Published
2024-09-05
Public version status
Update
Distribution status
Not 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
K170466000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170466000Automatic Blood Pressure Monitor Model LD-518 & LD-537Honsun (Nantong) Co., Ltd.2017-10-27DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970384254447PackageGS120Not in Commercial Distribution
06970384254440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697038425444716970384254447
06970384254440069703842544406970384254440

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543364560
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970384252163SCIANAres6A2026-07-30
16970384252160SCIANAres6A2026-07-30
26970384252167SCIANAres6A2026-07-30
06970384254518SCIANLD-562U2024-09-09
16970384250227HONSUNHS-30J2022-03-31
06970384250220HONSUNHS-30J2022-03-31
16970384254515/LD-562U2024-09-09
16970384250180SCIANLD5212022-03-31
16970384250616SCIANLD-5202022-03-31
16970384250623SCIANLD-5272022-03-31
16970384250630SCIANLD-562S2022-03-31
16970384250944SCIANLD-566S2022-03-31
06970384250183SCIANLD5212022-03-31
06970384250619SCIANLD-5202022-03-31
06970384250626SCIANLD-5272022-03-31
06970384250633SCIANLD-562S2022-03-31
06970384250947SCIANLD-566S2022-03-31
16970384250173SCIANLD5332022-03-31
16970384250210SCIANLD-753S2022-03-31
16970384250432SCIANLD-1002022-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06973826012363AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012370AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012387AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09