FDA.reportPublic FDA data

Livongo Demo Kit

Primary DI
00853553005271
Brand
Livongo Demo Kit
Company
LIVONGO HEALTH, INC
Model
Livongo
Catalog number
KIT00425
Device description
Livongo Demo Kit with BG300, 1 vial of Livongo Test strips, 1 bag of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Livongo Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133584000IN TOUCH BLOOD GLUCOSE MONITORING SYSTEMEoshealth, Inc.2014-09-08CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853553005271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853553005271008535530052718535530052710853553005271

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure0 KiloPascal75 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature41 Degrees Fahrenheit86 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
Kit
true
Lot or batch
true
Serial number
true
Expiration 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00010939958617TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2023-09-12
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10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
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10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
00011822002783TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2021-08-31
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
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