Medisante

Basic Information

• Brand Name: Medisante
• Primary DI: 04719878870016
• Version / Model: BC800 3G
• Company Name: EBM TECHNOLOGIES INCORPORATED
• Labeler DUNS: 657261272
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-24
• Public Version: 1
• Public Version Date: 2020-09-01
• Public Version Status: New
• Public Device Record Key: 38409ca4-8698-4a8c-9f16-3a1578b671c5

Device Description

BC800 3G Weight Scale is a digital monitor for home/domestic use which measures weight.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
FRI	Scale, Stand-On, Patient	General Hospital	880.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36020	Scale weight	A countermeasure that is produced in an exact unit of weight and intended to balance the weight of an object, typically on a mechanical scale, to produce a quantified measurement.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719878870016	GS1
Package	14719878870013	GS1	Box	5	In Commercial Distribution