MediBeacon® TGFR Reusable Sensor

Basic Information

• Brand Name: MediBeacon® TGFR Reusable Sensor
• Primary DI: 00860008387189
• Version / Model: TGFR-SE-00201-001
• 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: 1d335b50-f871-4597-8411-01246033bf28

Device Characteristics

• Single Use: No
• 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	00860008387196	GS1		5	In Commercial Distribution
Primary	00860008387189	GS1
Package	00860008387110	GS1		8	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
P230019	001