FDA.reportPublic FDA data

Microlife

Primary DI
14719003315044
Brand
Microlife
Company
MICROLIFE USA, INC.
Model
BP3SZ1-1CEN
Catalog number
WatchBP O3 2G
Device description
WatchBP O3 2G(BP3SZ1-1) CBP type
Published
2024-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719003315044PackageGS11In Commercial Distribution
24719003315041PackageGS110In Commercial Distribution
04719003315047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471900331504414719003315044
2471900331504124719003315041
04719003315047047190033150474719003315047

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176387785
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
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
04719003631284MicrolifeBP3SZ1-1AFIB2024-10-28
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
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
06973912940419IMDKShenzhen IMDK Medical Technology Co., LtdDXN2026-06-23
06973912940426IMDKShenzhen IMDK Medical Technology Co., LtdDXN2026-06-23
06926347900497POSTUREShenzhen Brav Electronic Technologies Co., Ltd.DXN2026-06-09
06953825911041ELERAShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911188sakerplusShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03