FDA.reportPublic FDA data

Teladoc Health, Inc.

Primary DI
00810079240609
Brand
Teladoc Health, Inc.
Company
Teladoc Health, Inc.
Model
BG500
Catalog number
KIT000040
Device description
Teladoc Refill Kit BG500
Published
2026-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810079240609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810079240609008100792406098100792406090810079240609

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancing device tipA sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit
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
079408533
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810079260010Teladoc Health, Inc.WM1500KIT0000312025-09-22
00810079240531Teladoc Health, Inc.BG500FG0000052026-02-17
00810079240548Teladoc Health, Inc.BG500 RDKIT0000412026-02-17
00810079240555Teladoc Health, Inc.BG500 WKKIT0000392026-02-17
00810079240562Teladoc Health, Inc.BG500OFG0000262026-02-17
00810079240579Teladoc Health, Inc.BG500OFG0000242026-02-17
00810079240586Teladoc Health, Inc.BG500OFG0000272026-02-17
00810079240593Teladoc Health, Inc.BG500OFG0000252026-02-17
00810079250042Teladoc Health, Inc.WM2000OFG0000322026-02-17
00810079250059Teladoc Health, Inc.WM2000 WKKIT0000422026-02-17
00810079260065Teladoc Health, Inc.HT2000OFG0000312026-02-17
00810079260089Teladoc Health, Inc.HT2000OFG0000292026-02-17
00810079260102Teladoc Health, Inc.HT2000KIT0000432026-02-17
00810079260003Teladoc Health, Inc.HT2000OFG0000302026-02-17
00810079240401Teladoc Health, IncBG300 - DGFG0000032025-10-10
00810079240418Teladoc Health, Inc.BG300OFG0000152025-10-10
00810079240425Teladoc Health, Inc.BG300 - MYFG0000042025-10-10
00810079240449Teladoc Health, Inc.BG300 - CHOFG0000172025-10-10
00810079240456Teladoc Health, Inc.BG300OFG0000182025-10-10
00810079240487Teladoc Health, Inc.BG300 WKKIT0000322025-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786890True IntegralTRUE INTEGRAL INCQRK2026-05-28
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
16945630142014STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142021STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142038STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142045STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142069STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630141291STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141307SinocareSterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141284STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-12-31
20197344111838MEDLINEMEDLINE INDUSTRIES, INC.QRK2025-10-22
16945630139311STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-09-10
16945630139328STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-09-10
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393408Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393415Sterilized Eol Auto LancetHLB CO.,LTDQRK2025-08-20
08809262393422Sterilized Eol Auto LancetHLB CO.,LTDQRK2025-08-20
08809262393439Sterilized Eol Auto LancetHLB CO.,LTDQRK2025-08-20
08809262393460Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393477Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393484Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393743SureComfort Safety LancetHLB CO.,LTDQRK2025-08-20
10673486002478GLUCOPAD TC-SMART+ Lancets KitTECO DIAGNOSTICSQRK2025-06-10
16945630136679suttersyncSterilance Medical (Suzhou) Inc.QRK2025-05-23
10673486002461GLUCOPAD TC-SMART+ Lancets KitTECO DIAGNOSTICSQRK2025-05-14
16945630136143TRANSTEKSterilance Medical (Suzhou) Inc.QRK2025-04-22