BlackBox

Basic Information

• Brand Name: BlackBox
• Primary DI: B963WS501C0
• Version / Model: WS-501C
• Company Name: Blackbox Remote Patient Monitoring LLC
• Labeler DUNS: 117652799
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-27
• Public Version: 1
• Public Version Date: 2022-08-04
• Public Version Status: New
• Public Device Record Key: 4cdb39de-a09a-4fac-9c03-71dc29744f08

Device Description

Cellular weight scale with a large platform and high weight capacity

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: 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: No
• 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
FRW	Scale, Patient	General Hospital	880.2720	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38211	Stand-on floor scale, electronic	An electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	BB4B963WS501C1	HIBCC	Carton	4	In Commercial Distribution
Primary	B963WS501C0	HIBCC

Customer Contacts

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