FDA.reportPublic FDA data

Lumitrace® (relmapirazin) Injection

Primary DI
00860008387165
Brand
Lumitrace® (relmapirazin) Injection
Company
MediBeacon Inc.
Model
TGFR-TA-00100-010
Published
2026-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
P230019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230019000MediBeacon® Transdermal GFR Measurement System (TGFR)Medibeacon, Inc.2025-01-17SDK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860008387169PackageGS110In Commercial Distribution
30860008387166PackageGS15In Commercial Distribution
00860008387165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086000838716920860008387169
3086000838716630860008387166
00860008387165008600083871658600083871650860008387165

GMDN Terms#

Term, Definition table
TermDefinition
Glomerular filtration rate analyserAn electrically-powered device intended to be used by a healthcare professional to assess kidney function at the point-of-care by measuring and recording glomerular filtration rate (GFR) over a period of hours based on renal clearance of a pre-injected fluorescent tracer agent. It includes integrated software and a display and is intended to be connected to a noninvasive transcutaneous fluorescence sensor (not included).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078731694
Device count
1
Manufacturing date on label
true

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
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
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
00860008387196MediBeacon® TGFR Reusable SensorMediBeacon Inc.SDK2026-03-01