FDA.reportPublic FDA data

LotFancy

Primary DI
06939663925068
Brand
LotFancy
Company
Sejoy Biomedical Co.,Ltd.
Model
11C-1850-D 
Published
2016-11-14
Public version status
Update
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
16939663925065PackageGS127In Commercial Distribution
06939663925068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693966392506516939663925065
06939663925068069396639250686939663925068

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.

Regulatory Flags#

DUNS number
545241999
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06939663982092sejoyHCG-1012023-07-29
06939663969901SejoyBG-710b2024-12-31
16939663969908SejoyBG-710b2024-12-31
06939663911474NeulastaMT-1012016-11-22
06939663913652DORM DOCMT-1112019-12-25
06939663920759LotFancy11A-1803-I 2016-11-30
06939663922128LotFancy11A-1807-M2016-11-30
06939663922135LotFancy11A-1808-N2016-11-30
06939663924429WELBYBSP-132017-10-20
06939663924702LotFancy11C-1826-F2016-11-30
06939663924719LotFancy11C-1831-K2016-11-30
06939663924931LotFancy11A-1804-J2016-11-30
06939663925051LotFancy11C-1851-E2016-11-18
26939663913656DORM DOCMT-1112019-12-25
06939663913065Family WellnessMT-46252017-04-05
06939663913072Family WellnessMT-46252017-04-05
06939663915991Family WellnessMT-1012017-04-08
06939663900034N/AMT-1012017-12-05
06939663911283Westchester MEDICAL CENTERMT-101O2017-11-04
06939663911498DORM DOCMT-1112018-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932825306057CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
06932825306064CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
00073796318321WIDE-RANGE D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00073796392437SMALL D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00816042016516FORAFORA CARE INC.DXN2026-07-20
00898939002758FORAFORA CARE INC.DXN2026-07-20
06953825911515N/AShenzhen Urion Technology Co., LtdDXN2026-07-16
00850044118670iHealthiHealth Labs Inc.DXN2026-07-14
00850044118687iHealthiHealth Labs Inc.DXN2026-07-14
00850078377234iHealthiHealth Labs Inc.DXN2026-07-14
06953825911416N/AShenzhen Urion Technology Co., LtdDXN2026-07-13
00845717011556N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
00845717011563N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040112842N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040113481N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040114358N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040114365N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040117397N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
MHC18602130N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06953825911294N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911300N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911317AlphamedShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911355N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911393N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
04250413403578Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413403585Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413406456Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07
04250413406463Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07
06927709404608JALIPShenzhen Jamr Technology Co., Ltd.DXN2026-07-06
06927709404622WellWinkShenzhen Jamr Technology Co., Ltd.DXN2026-07-06