by Humankind

Basic Information

• Brand Name: by Humankind
• Primary DI: 00850007634483
• Version / Model: BHK-DV1
• Company Name: By Humankind, Inc.
• Labeler DUNS: 117642980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-01
• Public Version: 1
• Public Version Date: 2023-07-10
• Public Version Status: New
• Public Device Record Key: ba1ad7fe-71d5-4934-be2b-9f835c20d800

Device Description

By Humankind, BHK-DV1 Product Profile: The refillable, durable glass container is protected with a silicone top. The side notch design makes it easy to refill and re-thread your floss. The floss is spun around a sugarcane-based bioplastic spool and shipped in a compostable pouch to eliminate single-use plastic from your oral care routine. Each refill spool has 30 yards of biodegradable silk floss. Refills are shipped in a compostable pouch made from kraft paper with a sugar-based lining (pbat). Each refill eliminates 0.89oz of single-use plastic waste.

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
JES	Floss, Dental	Dental	872.6390	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64844	Dental floss dispenser	A manual device, similar to a bench tape dispenser, intended to be used to hold and facilitate the cutting of dental floss sections by an operator, typically with minimal contact to prevent cross-contamination; it is intended for use in a clinical setting or in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850007634483	GS1

Customer Contacts

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