BIOS Living

Basic Information

• Brand Name: BIOS Living
• Primary DI: 00057475700355
• Version / Model: 70035
• Company Name: Thermor Ltd
• Labeler DUNS: 246883458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-08
• Public Version: 1
• Public Version Date: 2023-11-16
• Public Version Status: New
• Public Device Record Key: e8b733c2-e2aa-410a-94f7-2364c36da137

Device Description

Diabetic Socks, Beige, Medium

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
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	880.5780	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58831	Antimicrobial sock	A tubular, fabric device intended to be worn on the feet of a patient to help maintain foot health and reduce the growth of fungi and bacteria through inclusion of an antimicrobial agent [e.g., pure cotton yarn containing silver (Ag) nanoparticles]. It is typically indicated for a patient who suffers from athlete’s foot, diabetic foot, neurological sensory disorders (e.g., unable to feel micro traumas, touch, or temperature), and impaired blood circulation; it is generally intended to reduce the risk of primary and secondary infection. The device is normally available for daily use in the home or healthcare facility. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20057475700359	GS1	Case	3	In Commercial Distribution
Primary	00057475700355	GS1
Package	10057475700352	GS1	Case	8	In Commercial Distribution