Fat Loss Monitor HBF-306CAN

GUDID 00073796306342

Omron Fat Loss Monitor

Omron Healthcare, Inc.

Bioelectrical body composition analyser

• Primary Device ID: 00073796306342
• NIH Device Record Key: b44e1bac-0e29-484e-9726-5c2fbdda1767
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fat Loss Monitor
• Version Model Number: HBF-306CAN
• Catalog Number: HBF-306CAN
• Company DUNS: 054318779
• Company Name: Omron Healthcare, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: true
• Manufacturing Date: false
• 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: true

Customer Support Contacts

• Phone: 1-800-634-4350
• Email: quality@omron.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796306342 [Primary]
GS1	10073796306349 [Package]; Package: Inner Carton [3 Units]; In Commercial Distribution
GS1	20073796306346 [Package]; Contains: 10073796306349; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011652

FDA Product Code

• MNW: Analyzer, Body Composition

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Fat Loss Monitor]

• 00073796306342: Omron Fat Loss Monitor
• 00073796306304: HBF-306CN