FDA UDI
In Commercial Distribution
🇺🇸 United States
Lumitrace® (relmapirazin) Injection
DI: 00860008387165
·
Model: TGFR-TA-00100-010
·
MediBeacon Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Lumitrace® (relmapirazin) Injection
- Primary DI
- 00860008387165
- Version / Model
- TGFR-TA-00100-010
- 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
- 30c6c8cb-6acc-4e4a-b156-c433ad9c873a
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 66145 | Glomerular filtration rate analyser | An 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860008387165 | GS1 | ||||
| Package | 20860008387169 | GS1 | 10 | In Commercial Distribution | ||
| Package | 30860008387166 | GS1 | 5 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P230019 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius