FDA.reportPublic FDA data

Truvitals Smart Wrist Blood Pressure Monitor with Bluetooth (BPW500)

Primary DI
00843812175197
Brand
Truvitals Smart Wrist Blood Pressure Monitor with Bluetooth (BPW500)
Company
C&A Marketing, Inc.
Model
GEBPW500
Device description
Wrist type blood pressure monitor
Published
2023-01-10
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200346000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200346000Wrist Type Blood Pressure MonitorAvita Corporation2020-12-17DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843812175197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843812175197008438121751978438121751970843812175197

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
134723316
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843812168434Wave Blue Nitrile Examination Gloves Powder FreeLargeWVEBNGL2023-02-22
00843812168458Wave Blue Nitrile Examination Gloves Powder FreeX LargeWVEBNGXL2023-02-22
00843812168496Wave Blue Nitrile Examination Gloves Powder FreeSmallWVEBNGS2023-02-22
00843812168502Wave Blue Nitrile Examination Gloves Powder FreeMediumWVEBNGM2023-02-22
00843812172783Truvitals Upper Arm Blood Pressure Monitor (BPA200)GEBPA2002023-01-10
00843812173254Truvitals Upper Arm Blood Pressure Monitor (BPA400)GEBPA4002023-01-10
00843812173278Truvitals Wrist Blood Pressure Monitor (BPW100)GEBPW1002023-01-10
00843812175180Truvitals Smart Upper Arm Blood Pressure Monitor with Bluetooth (BPA600)GEBPA6002023-01-10

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Primary DI, Brand, Company table
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