FDA.reportPublic FDA data

Livongo

Primary DI
00810079240142
Brand
Livongo
Company
LIVONGO HEALTH, INC
Model
BG300 - MX
Catalog number
OFG000002
Device description
BG300 control solution, MX
Published
2025-09-25
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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

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
00810079240142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810079240142008100792401428100792401420810079240142

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
1-800-945-4355rc_team@teladochealth.com

Regulatory Flags#

DUNS number
829984561
Device count
1
Lot or batch
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
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
00853553005042Livongo Blood Pressure MonitorHT900OFG051912022-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSJJX2022-08-09
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164489uTASWako DCP Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164496uTASWako DCP Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
00021292008390TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00021292008406TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21