FDA.reportPublic FDA data

Silvercrest

Primary DI
14056232708217
Brand
Silvercrest
Company
LIDL US, LLC
Model
IAN: 326870_1901
Catalog number
659.59
Device description
Bluetooth Blood Pressure Monitor 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 to 16.5 in (22cm to 42cm), in a non-invasive way.
Published
2019-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
14056232708217PackageGS14In Commercial Distribution
04056232708210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1405623270821714056232708217
04056232708210040562327082104056232708210

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
04055334329484SilvercrestIAN: 366723_2101653.182021-06-30
07290016625110Tampons by LidlBLIGR362021-02-28
14056489267390Tampons by LidlBLIXC362021-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
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00885403529644Acumen IQ CuffBecton, Dickinson And CompanyDXN2026-07-31
00885403529651Acumen IQ CuffBecton, Dickinson And CompanyDXN2026-07-31
00885403533191Acumen IQ PlusBecton, Dickinson And CompanyDXN2026-07-31
00885403533207VitaWaveBecton, Dickinson And CompanyDXN2026-07-31
00885403529637Acumen IQBecton, Dickinson And CompanyDXN2026-07-29
00885403529668Acumen IQBecton, Dickinson And CompanyDXN2026-07-29
00885403529774ClearSight JrBecton, Dickinson And CompanyDXN2026-07-29
00885403529781ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529798ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529811ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529828VitaWaveBecton, Dickinson And CompanyDXN2026-07-29
00194346614035equateWAL-MART STORES, INC.DXN2026-07-28
06953825911683SAKER UltraShenzhen Urion Technology Co., LtdDXN2026-07-27
06953825911645N/AShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911652ANOVATORShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911669SPASTACISEShenzhen Urion Technology Co., LtdDXN2026-07-24
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