FDA.reportPublic FDA data

Silvercrest

Primary DI
04055334329484
Brand
Silvercrest
Company
LIDL US, LLC
Model
IAN: 366723_2101
Catalog number
653.18
Device description
Bluetooth Blood Pressure Monitor (SBM69)Upper-arm blood pressure monitor intended to measure and monitor the arterial blood pressure values and the heart rates of adults with an arm circumference of 8.7 in to16.5 in (22cm to 42cm), in a non-invasive way.
Published
2021-06-30
Public version status
New
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
14055334329481PackageGS14In Commercial Distribution
04055334329484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1405533432948114055334329481
04055334329484040553343294844055334329484

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
079389709
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055332060105SilvercrestIAN: 391892_2201656.892022-11-20
14055332060102SilvercrestIAN: 391892_2201656.892022-11-20
04056489267393Tampons by LidlBLIXC362021-02-28
04056489466642Tampons by LidlBLIGR362021-05-29
04056489466659Tampons by LidlBLIGS362021-02-28
04056232708227SilvercrestIAN 326857_1901453.752019-08-19
14056232708224SilvercrestIAN 326857_1901453.752019-08-19
04055334330404SilvercrestIAN 387871_2101454.122021-08-30
04055334351188SilvercrestSWKK60A1238.192021-10-31
04055334351195SilvercrestSKH60A1238.202021-10-31
04055334216562SilvercrestSSHK60E5 (Grey)218.632021-10-31
04055334216579SilvercrestSSHK60E5 (Beige)218.632021-10-31
14055334351185SilvercrestSWKK60A1238.192021-10-31
14055334351192SilvercrestSKH60A1238.202021-10-31
04055334329453SilvercrestIAN 366721_2101 - SBF77 Black760.622021-10-08
04055334329460SilvercrestIAN 366721_2101 - SBF77 White760.632021-10-08
04055334330084SilvercrestIAN 387870_2101793.992021-08-30
07290016625110Tampons by LidlBLIGR362021-02-28
14056489267390Tampons by LidlBLIXC362021-02-28
14056489466656Tampons by LidlBLIGS362021-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911225AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911232AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
06976528061608Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06976528061615Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06932825303216TeleRPMGuangdong Transtek Medical Electronics Co.,LtdDXN2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2026-06-02
06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
06976528060335Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060342Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060359Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060366Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060373Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060380Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27