MediBeacon® TGFR Monitor (US)
- Primary DI
- 00850082050000
- Brand
- MediBeacon® TGFR Monitor (US)
- Company
- MediBeacon Inc.
- Model
- TGFR-MB-01002-001
- 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 |
|---|
| SDK | Transdermal Test For Assessment Of Glomerular Filtration Rate |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| SDK | Transdermal Test For Assessment Of Glomerular Filtration Rate | Unknown | 3 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| P230019 | 001 | MediBeacon® Transdermal GFR Measurement System (TGFR) | Medibeacon, Inc. | 2025-01-17 | SDK |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00850082050000 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00850082050000 | 00850082050000 | 850082050000 | 0850082050000 |
GMDN Terms
| Term | Definition |
|---|
| 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). |
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 | Catalog | Published |
|---|
| 10860008387131 | MediBeacon® TGFR Disposable Ring | D200 | | 2026-03-01 |
| 00860008387165 | Lumitrace® (relmapirazin) Injection | TGFR-TA-00100-010 | | 2026-03-01 |
| 00860008387196 | MediBeacon® TGFR Reusable Sensor | TGFR-SE-00201-001 | | 2026-03-01 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 10860008387131 | MediBeacon® TGFR Disposable Ring | MediBeacon Inc. | SDK | 2026-03-01 |
| 00860008387165 | Lumitrace® (relmapirazin) Injection | MediBeacon Inc. | SDK | 2026-03-01 |
| 00860008387196 | MediBeacon® TGFR Reusable Sensor | MediBeacon Inc. | SDK | 2026-03-01 |