1BYONE

Basic Information

• Brand Name: 1BYONE
• Primary DI: 00850014261016
• Version / Model: TMB-1585-BS
• Company Name: 1BYONEPRODUCTS INC.
• Labeler DUNS: 845019202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-11
• Public Version: 2
• Public Version Date: 2020-06-05
• Public Version Status: Update
• Public Device Record Key: 4cfdb5db-92c9-4b6e-bbc7-9b63409f0989

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: No
• 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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45618	Telemetric sphygmomanometer	An electrically-powered device designed to noninvasively measure blood pressure by automatically inflating and deflating a cuff that typically fits around a limb (arm or thigh); it may in addition measure the heart rate and mean arterial pressure. It typically incorporates a display and controls, and may include a blood pressure cuff with connection tubing. The measurements can be wirelessly sent to a medical facility for analysis, typically using a computer or mobile phone with a dedicated software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850014261016	GS1
Package	10850014261013	GS1	outer carton	20	In Commercial Distribution