FDA.reportPublic FDA data

Livongo Blood Pressure Monitor

Primary DI
00853553005042
Brand
Livongo Blood Pressure Monitor
Company
LIVONGO HEALTH, INC
Model
HT900
Catalog number
OFG05191
Device description
HT900 Device, Cellular Blood Pressure Monitor (4G)
Published
2022-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00853553005042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853553005042008535530050428535530050420853553005042

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-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 not designed to be portable and is typically used bedside.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.945.4355membersupport@livongo.com

Regulatory Flags#

DUNS number
829984561
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00810079240364Livongo Health, Inc. by Teladoc Health, Inc.BG300 WK - Bridge CH or MYKIT0000262025-10-14
00810079240524Livongo Health, Inc. by Teladoc Health, Inc. BG300 - RRD RKKIT0000372025-10-14
00810079240142LivongoBG300 - MXOFG0000022025-09-25
00853553005028In Touch Glucose Control SolutionsIn TouchOFG001402016-09-24
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00853553005066In Touch Sterile LancetsIn TouchOFG001422016-09-24
00853553005097In Touch Welcome KitIn TouchKIT001452016-09-24
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00853553005141In Touch Lancing DeviceIn TouchOFG001562016-09-24
00853553005158In Touch Glucose Control SolutionIn TouchOFG001552016-09-24
00853553005189In Touch Lancing DeviceIn TouchOFG002042016-09-24
00810079260027Teladoc Health, IncScale, 4G Cellular Weight Management, Bridge BrandKIT108142023-08-25
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00853553005646Teladoc Health, IncWelcome Kit, 4G Cellular Body Scale WM1500KIT063072023-08-25
00853553005738Livongo Test Strips - MexicoLivongoOFG103532022-09-20
00853553005752Livongo WM1500 Welcome KitWM1500 Welcome KitKIT108142022-04-22

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