FDA.reportPublic FDA data

Teladoc Health, Inc

Primary DI
00853553005646
Brand
Teladoc Health, Inc
Company
LIVONGO HEALTH, INC
Model
Welcome Kit, 4G Cellular Body Scale WM1500
Catalog number
KIT06307
Device description
KIT, WELCOME, 4G CELLULAR BODY SCALE WM15001 Scale, 1 Scale User Guide, 4 AA Alkaline Batteries
Published
2023-08-25
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
FRIScale, Stand-On, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRIScale, Stand-On, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853553005646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853553005646008535530056468535530056460853553005646

GMDN Terms#

Term, Definition table
TermDefinition
Stand-on floor scale, electronicAn electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal105 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure80 KiloPascal105 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.945.4355membersupport@livongo.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853553005615Teladoc Health, IncWM1500 Modem ModuleOFG063082023-08-25
00810079240265Livongo Health, Inc. by Teladoc Health, Inc. BG300 - LVL, CH & MXKIT0000042025-10-14
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
00853553005035In Touch Blood Glucose MeterBG200FG001632016-09-24
00853553005059Inb Touch Lancing DeviceIn TouchOFG001412016-09-24
00853553005066In Touch Sterile LancetsIn TouchOFG001422016-09-24
00853553005097In Touch Welcome KitIn TouchKIT001452016-09-24
00853553005103In Touch Refill KitIn TouchKIT001472016-09-24
00853553005110In Touch Blood Glucose Test StripsIn TouchOFG001542016-09-24
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
00810079260058Teladoc Health, IncWM1500 Scale, BG95-M2OFG0000132023-08-25
00853553005738Livongo Test Strips - MexicoLivongoOFG103532022-09-20
00853553005752Livongo WM1500 Welcome KitWM1500 Welcome KitKIT108142022-04-22
00853553005042Livongo Blood Pressure MonitorHT900OFG051912022-04-05

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