Balance

GUDID 10863398000277

Body composition scale.

LEXINGTON WELLNESS HOLDINGS INC.

Bioelectrical body composition analyser

• Primary Device ID: 10863398000277
• NIH Device Record Key: b6e60141-3947-4bb3-8607-e16999749fbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balance
• Version Model Number: S-5
• Company DUNS: 079437338
• Company Name: LEXINGTON WELLNESS HOLDINGS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863398000270 [Primary]
GS1	10863398000277 [Package]; Contains: 00863398000270; Package: Carton [6 Units]; In Commercial Distribution
GS1	20863398000274 [Package]; Contains: 00863398000270; Package: Case [6 Units]; In Commercial Distribution

FDA Product Code

• PUH: Analyzer, Body Composition, Exempt

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: 2020-11-09
• Device Publish Date: 2020-10-30

On-Brand Devices [Balance]

• 10863398000260: Body composition scale.
• 10863398000246: Body composition scale.
• 10863398000277: Body composition scale.
• 10860005561732: Body composition scale. 200kg model.