IdealSmart

GUDID 00834450009159

Body composition scale.

LEXINGTON WELLNESS HOLDINGS INC.

Bioelectrical body composition analyser

• Primary Device ID: 00834450009159
• NIH Device Record Key: 3ee7c94a-f2ce-42af-a267-d97b7f91fe70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IdealSmart
• Version Model Number: S-3
• 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	00834450009142 [Primary]
GS1	00834450009159 [Package]; Contains: 00834450009142; Package: Carton [4 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: 2019-02-15
• Device Publish Date: 2019-01-15

Devices Manufactured by LEXINGTON WELLNESS HOLDINGS INC.

• 10860005561749 - Beat: 2025-03-04
• 10860005561732 - Balance: 2023-08-24 Body composition scale. 200kg model.
• 00863398000225 - Beat: 2023-07-04 Upper arm blood pressure monitor.
• 10860005561725 - Touch: 2021-09-08 Pulse oximeter.
• 00860005561704 - Scan: 2021-02-09 Blood glucose meter test strips.
• 00863398000294 - Scan: 2021-02-09 Blood glucose meter.
• 10863398000277 - Balance: 2020-11-09 Body composition scale.
• 10863398000284 - Beat: 2020-10-09 Upper arm blood pressure monitor.