BIOS Living

Basic Information

• Brand Name: BIOS Living
• Primary DI: 00057475590888
• Version / Model: 59088
• Company Name: Thermor Ltd
• Labeler DUNS: 246883458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-19
• Public Version: 1
• Public Version Date: 2023-09-27
• Public Version Status: New
• Public Device Record Key: 61d0ae67-7214-414e-bd08-b42291e3b4e9

Device Description

Acupressure Mat and Pillow Set

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: No
• 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
LYG	Massager, Therapeutic, Manual	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64144	Acupressure applicator, reusable	A small device intended for the application of noninvasive, non-powered acupressure to acupuncture points on the skin for the treatment of a variety of conditions/disorders. It is made of polymer materials and is supplied in a variety of shapes and sizes with differently shaped contact points; it is typically held on the skin with slight manual pressure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00057475590888	GS1
Package	10057475590885	GS1	Case	6	In Commercial Distribution