Dario Smart Scale (Cellular) - Weight Management System

GUDID 00850033352023

The Dario Smart Scale (Cellular) - Weight Management System is intended for measuring the body weight of adults and children (aged 10-17 years old). It is intended for indoor use only.

LABSTYLE INNOVATION LTD

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• Primary Device ID: 00850033352023
• NIH Device Record Key: b714da12-7400-41ad-b746-6f6df03d85ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dario Smart Scale (Cellular) - Weight Management System
• Version Model Number: 1169-05
• Company DUNS: 600039072
• Company Name: LABSTYLE INNOVATION LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033352023 [Primary]

FDA Product Code

• FRI: Scale, Stand-On, Patient

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: 2021-10-25
• Device Publish Date: 2021-10-17

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