FDA device listing
MBP-WC-406 Miracle of the Sea Miracle Bandage Plus Wound Care,Miracle Dressing,MPD-PI-413 MBET Health Miracle…
FDA device listing 1944235623 · MBET Health, LLC
Key facts
| Proprietary names | MBP-WC-406 Miracle of the Sea Miracle Bandage Plus Wound Care,Miracle Dressing,MPD-PI-413 MBET Health Miracle Professional Dressing Peel and Place Pressure Injury Prevention,MPD-WC-204 MBET Health Miracle Professional Dressing Peel and Place Wound Care,MPD-WC-406 MBET Health Miracle Professional Dressing Peel and Place Wound Care |
|---|---|
| Owner/operator | MBET Health, LLC |
| Owner/operator number | 10085475 |
| Product codes | KGX |
| Device names | KGX - Tape And Bandage, Adhesive |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5240 |
| Review panels | General Hospital |
| Registered establishments | MBET HEALTH, LLC |
| Establishment registrations | 3023122974 |
| FEI numbers | 3023122974 |
| Establishment operations | Manufacturer, Remanufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database