FDA.reportPublic FDA data

MediBeacon® TGFR Reusable Sensor

Primary DI
00860008387189
Brand
MediBeacon® TGFR Reusable Sensor
Company
MediBeacon Inc.
Model
TGFR-SE-00201-001
Published
2026-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
SDKTransdermal Test For Assessment Of Glomerular Filtration Rate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDKTransdermal Test For Assessment Of Glomerular Filtration RateUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230019001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230019001MediBeacon® Transdermal GFR Measurement System (TGFR)Medibeacon, Inc.2025-01-17SDK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008387110PackageGS18In Commercial Distribution
00860008387196PackageGS15In Commercial Distribution
00860008387189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008387110008600083871108600083871100860008387110
00860008387196008600083871968600083871960860008387196
00860008387189008600083871898600083871890860008387189

GMDN Terms#

Term, Definition table
TermDefinition
Glomerular filtration rate transcutaneous sensor, reusableA 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.

Regulatory Flags#

DUNS number
078731694
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008387134MediBeacon® TGFR Disposable RingD2002026-03-01
00850082050000MediBeacon® TGFR Monitor (US)TGFR-MB-01002-0012026-03-01
10860008387131MediBeacon® TGFR Disposable RingD2002026-03-01
00860008387165Lumitrace® (relmapirazin) InjectionTGFR-TA-00100-0102026-03-01
00860008387196MediBeacon® TGFR Reusable SensorTGFR-SE-00201-0012026-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008387134MediBeacon® TGFR Disposable RingMediBeacon Inc.SDK2026-03-01
00850082050000MediBeacon® TGFR Monitor (US)MediBeacon Inc.SDK2026-03-01
10860008387131MediBeacon® TGFR Disposable RingMediBeacon Inc.SDK2026-03-01
00860008387165Lumitrace® (relmapirazin) InjectionMediBeacon Inc.SDK2026-03-01
00860008387196MediBeacon® TGFR Reusable SensorMediBeacon Inc.SDK2026-03-01