FDA.reportPublic FDA data

Microlife

Primary DI
04719003631284
Brand
Microlife
Company
MICROLIFE USA, INC.
Model
BP3SZ1-1AFIB
Published
2024-10-28
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719003631281PackageGS110In Commercial Distribution
04719003631284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471900363128114719003631281
04719003631284047190036312844719003631284

GMDN Terms#

Term, Definition table
TermDefinition
Arrythmia-detection blood pressure ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for the 24-hour recording of blood pressure and detection of cardiac arrythmias [e.g., atrial fibrillation (AF)]; it may in addition measure the heart rate and mean arterial pressure. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer or mobile phone with a dedicated software. The device typically incorporates a display and controls, and may include a blood pressure cuff with connection tubing.

Regulatory Flags#

DUNS number
176387785
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
04719003406516MicrolifeFR1MZ1-B2026-01-31
14719003406513MicrolifeFR1MZ1-B2026-01-31
00642632472000MicrolifeNEB2002020-05-13
00642632900251microlifeBPHJE2-D2025-03-21
10642632900258microlifeBPHJE2-D2025-03-21
04719003315085MicrolifeCRO-BP3MX1-3C12025-03-11
06970388169511MicrolifeCuff-L-WBPA2025-02-10
16970388169518MicrolifeCuff-L-WBPA2025-02-10
04719003315030MicrolifeBP3SZ1-1WatchBP O3 2G2024-11-27
04719003315047MicrolifeBP3SZ1-1CENWatchBP O3 2G2024-11-27
14719003315037MicrolifeBP3SZ1-1WatchBP O3 2G2024-11-27
14719003315044MicrolifeBP3SZ1-1CENWatchBP O3 2G2024-11-27
06970388169160MicrolifeBP3MX1-32024-10-28
06970388169221MicrolifeCuff-LXL-WBPH2024-10-28
06970388169429MicrolifeCuff-L-WBPH2024-10-28
06970388169528MicrolifeCuff-LXL-WBPA2024-10-28
14719003631281MicrolifeBP3SZ1-1AFIB2024-10-28
16970388169167MicrolifeBP3MX1-32024-10-28
16970388169228MicrolifeCuff-LXL-WBPH2024-10-28
16970388169426MicrolifeCuff-L-WBPH2024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06973826012394AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012400AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09