Teladoc Health, Inc. OFG000019

GUDID 00810079240463

Teladoc Control Solution, BG300 - CH

Teladoc Health, Inc.

Glucose IVD, control
Primary Device ID00810079240463
NIH Device Record Key0ec9a01b-d239-47c5-9205-32fbf5fe5e43
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeladoc Health, Inc.
Version Model NumberBG300 - CH
Catalog NumberOFG000019
Company DUNS079408533
Company NameTeladoc Health, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-945-4355
Emailrc_team@teladochealth.com
Phone1-800-945-4355
Emailrc_team@teladochealth.com
Phone1-800-945-4355
Emailrc_team@teladochealth.com
Phone1-800-945-4355
Emailrc_team@teladochealth.com
Phone1-800-945-4355
Emailrc_team@teladochealth.com
Phone1-800-945-4355
Emailrc_team@teladochealth.com
Phone1-800-945-4355
Emailrc_team@teladochealth.com
Phone1-800-945-4355
Emailrc_team@teladochealth.com
Phone1-800-945-4355
Emailrc_team@teladochealth.com
Phone1-800-945-4355
Emailrc_team@teladochealth.com
Phone1-800-945-4355
Emailrc_team@teladochealth.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100810079240463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-03
Device Publish Date2025-09-25

On-Brand Devices [Teladoc Health, Inc.]

00810079260010Welcome Kit - Teladoc Branded WM1500
00810079240494Teladoc Refill Kit BG300 - RRD
00810079240470Teladoc Control Solution, BG300 MX
00810079240463Teladoc Control Solution, BG300 - CH
00810079240432Teladoc Test Strips BG300, MX

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