FDA device listing
Calcium Alginate Dressing,Gelling Fiber Wound Dressing,Heel Foam Dressing (No Border),Heel Foam Dressing (With…
FDA device listing 1320325420 · VIVE Health LLC
Key facts
| Proprietary names | Calcium Alginate Dressing,Gelling Fiber Wound Dressing,Heel Foam Dressing (No Border),Heel Foam Dressing (With Border),Hydrocolloid Bordered Dressing,Lidocaine Patches 4%,Non Adherent Pads,Super Absorbant Wound Dressing,Waterproof Shower Protector Patch |
|---|---|
| Owner/operator | VIVE Health LLC |
| Owner/operator number | 10047487 |
| Product codes | NAC |
| Device names | NAC - Dressing, Wound, Hydrophilic |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4018 |
| Review panels | General & Plastic Surgery |
| Registered establishments | VIVE Health LLC |
| Establishment registrations | 3011191255 |
| FEI numbers | 3011191255 |
| Establishment operations | Repackager/Relabeler |
| 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