Teladoc Health, Inc. OFG000019

GUDID 00810079240463

Teladoc Control Solution, BG300 - CH

Teladoc Health, Inc.

Glucose IVD, control

• Primary Device ID: 00810079240463
• NIH Device Record Key: 0ec9a01b-d239-47c5-9205-32fbf5fe5e43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teladoc Health, Inc.
• Version Model Number: BG300 - CH
• Catalog Number: OFG000019
• Company DUNS: 079408533
• Company Name: Teladoc Health, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com
• Phone: 1-800-945-4355
• Email: rc_team@teladochealth.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810079240463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133584

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-03
• Device Publish Date: 2025-09-25

On-Brand Devices [Teladoc Health, Inc.]

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