FDA device listing
Aplicare Convenience Kits,Aplicare Dressing Change Kit
FDA device listing 2008288700 · Amphenol Critical Medical Technologies, LLC
Key facts
| Proprietary names | Aplicare Convenience Kits,Aplicare Dressing Change Kit |
|---|---|
| Owner/operator | Amphenol Critical Medical Technologies, LLC |
| Owner/operator number | 9030406 |
| Product codes | NEC |
| Device names | NEC - Bandage, Liquid, Skin Protectant |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5090 |
| Review panels | General Hospital |
| Registered establishments | Integra Biotechnical, SA de CV |
| Establishment registrations | 3009746061 |
| FEI numbers | 3009746061 |
| Establishment operations | Contract Manufacturer |
| 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