FDA.reportPublic FDA data

sunmark

Primary DI
00010939953803
Brand
sunmark
Company
STRATEGIC SOURCING SERVICES LLC
Model
BP3MV1-3BSMARK
Published
2020-08-07
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
10010939953800PackageGS16In Commercial Distribution
00010939953803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001093995380010010939953800
00010939953803000109399538030109399538030010939953803

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
116956644
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00052569133231Health Mart0525691332312020-07-31
00052569133408Health Mart0525691334082020-07-31
00052569133248Health Mart0525691332482020-07-31
00052569134955Health Mart0525691349552020-07-31
00010939959201Health Mart0109399592012024-02-15
00010939959218Health Mart0109399592182024-02-15
00010939959225Health Mart0109399592252024-02-15
00010939959249Health Mart0109399592492024-02-15
00010939959256Health Mart010939959256 2024-02-15
00010939959270Health Mart0109399592702024-02-15
00010939959294Health Mart0109399592942024-02-15
00010939959324Health Mart0109399593242024-02-15
00010939959348Health Mart0109399593482024-02-15
20010939959205Health Mart0109399592012024-02-15
20010939959212Health Mart0109399592182024-02-15
20010939959229Health Mart0109399592252024-02-15
20010939959243Health Mart0109399592492024-02-15
20010939959250Health Mart010939959256 2024-02-15
20010939959274Health Mart0109399592702024-02-15
20010939959298Health Mart0109399592942024-02-15

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Primary DI, Brand, Company table
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09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
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09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
06953825911799SAKERShenzhen Urion Technology Co., LtdDXN2026-08-17
06920485308542BSXShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-14