Escali

Basic Information

• Brand Name: Escali
• Primary DI: 00854202006502
• Version / Model: BFBW180
• Company Name: ESCALI CORP
• Labeler DUNS: 072924579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2019-11-27
• Public Version: 1
• Public Version Date: 2019-12-05
• Public Version Status: New
• Public Device Record Key: 5fbedb36-4e4d-4dcd-be00-697633d20d19

Device Description

Digital Body Fat/Water Scale, Retail Packaging

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• 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
PUH	Analyzer, Body Composition, Exempt	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
Package	00854202006519	GS1	Master Carton	4	In Commercial Distribution
Primary	00854202006502	GS1
Unit of Use	00854202006526	GS1