BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Teladoc Health, Inc.

DI: 00810079240517 · Model: BG300 RD · Teladoc Health, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Teladoc Health, Inc.
Primary DI: 00810079240517
Version / Model: BG300 RD
Catalog Number: KIT000036
Company Name: Teladoc Health, Inc.
Labeler DUNS: 079408533
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-10-10
Public Version: 1
Public Version Date: 2025-10-20
Public Version Status: New
Public Device Record Key: b404fd80-e2b3-4137-8985-c005743b8c64

Device Description

Teladoc Replacement Device Kit

Device Characteristics

Single Use: No
Prescription Use (Rx): No
Over the Counter (OTC): Yes
Kit: Yes
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62645	Glucose analyser IVD, home-use	An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; 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. This analyser is typically included in a blood glucose monitoring system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810079240517	GS1

Customer Contacts

Phone: 1-800-945-4355
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K133584	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -13 – 115 Degrees Fahrenheit
Type: Storage Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: 41 – 113 Degrees Fahrenheit
Type: Handling Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity
Type: Handling Environment Atmospheric Pressure
Temperature Range: 75 – 101 KiloPascal