Teladoc Health, Inc

Basic Information

• Brand Name: Teladoc Health, Inc
• Primary DI: 00810079260027
• Version / Model: Scale, 4G Cellular Weight Management, Bridge Branded, WM1500
• Catalog Number: KIT10814
• Company Name: LIVONGO HEALTH, INC
• Labeler DUNS: 829984561
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-25
• Public Version: 1
• Public Version Date: 2023-09-04
• Public Version Status: New
• Public Device Record Key: f2b82da4-9720-439d-958e-ad4d3ca605d3

Device Description

SCALE, 4G CELLULAR WEIGHT MANAGEMENT, BRIDGE BRANDED, WM1500

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
FRI	Scale, Stand-On, Patient	General Hospital	880.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38211	Stand-on floor scale, electronic	An electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810079260027	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 80 – 105 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 80 – 105 KiloPascal