Ozeri

Basic Information

• Brand Name: Ozeri
• Primary DI: 00815817012333
• Version / Model: ZB13-W
• Company Name: COMMONPATH LLC
• Labeler DUNS: 963223677
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 495a746e-1388-43ad-9978-ec577df9b9be

Device Description

Bathroom scale body fat analyzer. Support up to 8 users. Scale supports TARE function. Default unit is LB. Units - kg/lb/st. Batteries included. Utilizes 4 high precision GX sensors to weigh up to 440 pounds (200 kilograms) in 0.2 lbs or 0.1 kg increments with Step On technology. Elegant reflective surface is made of high quality impact-resistant tempered glass, which is 4 times stronger than normal glass. Color- White. This scale is not for clinical or diagnostic use.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNW	Analyzer, Body Composition	Cardiovascular	870.2770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36022	Bioelectrical body composition analyser	An electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815817012333	GS1
Package	10815817012330	GS1	Gift box	1	In Commercial Distribution
Package	20815817012337	GS1	Carton	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]