FDA.reportPublic FDA data

MediBeacon® TGFR Reusable Sensor

Primary DI
00860008387196
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
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078731694
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008387134MediBeacon® TGFR Disposable RingD2002026-03-01
00860008387189MediBeacon® TGFR Reusable SensorTGFR-SE-00201-0012026-03-01
00850082050000MediBeacon® TGFR Monitor (US)TGFR-MB-01002-0012026-03-01
10860008387131MediBeacon® TGFR Disposable RingD2002026-03-01
00860008387165Lumitrace® (relmapirazin) InjectionTGFR-TA-00100-0102026-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008387134MediBeacon® TGFR Disposable RingMediBeacon Inc.SDK2026-03-01
00860008387189MediBeacon® TGFR Reusable SensorMediBeacon 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