AccessGUDID - DEVICE: Teladoc Health, Inc (00810079260003)

GUDID

Device Identifier (DI) Information

Brand Name: Teladoc Health, Inc
Version or Model: WM1500 Modem Module
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OFG06308
Company Name: LIVONGO HEALTH, INC

Primary DI Number: 00810079260003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829984561 *Terms of Use

Device Description: WM1500, Modem Module FCC ID: XMR201707BG96

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRI	Scale, Stand-On, Patient

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 80 and 105 KiloPascal
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 80 and 105 KiloPascal
Storage Environment Humidity: less than 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c671756a-c844-4b5d-9b98-d146129bc298
Public Version Date: September 04, 2023
Public Version Number: 1
DI Record Publish Date: August 25, 2023