MediBeacon® TGFR Disposable Ring

Basic Information

• Brand Name: MediBeacon® TGFR Disposable Ring
• Primary DI: 00860008387134
• Version / Model: D200
• Company Name: MediBeacon Inc.
• Labeler DUNS: 078731694
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-01
• Public Version: 1
• Public Version Date: 2026-03-09
• Public Version Status: New
• Public Device Record Key: 6f94a578-feba-4797-881b-30f2f05dc57d

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
SDK	Transdermal Test For Assessment Of Glomerular Filtration Rate	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
66146	Glomerular filtration rate transcutaneous sensor, reusable	A noninvasive electronic sensor designed to be used by a healthcare professional for the transcutaneous activation and detection of a pre-injected fluorescent tracer agent in tissues to facilitate point-of-care glomerular filtration rate (GFR) measurements. It includes a light(s) for tracer agent fluorescence activation and photodiodes for light detection. It is attached to the patient at the skin surface and connected to a dedicated analyser (not included) for GFR measurements. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860008387131	GS1		25	In Commercial Distribution
Primary	00860008387134	GS1
Package	20860008387138	GS1		4	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
P230019	001