FDA device listing
Affix Clip
FDA device listing 1988049178 · Affix Medical
Key facts
| Proprietary names | Affix Clip |
|---|---|
| Owner/operator | Affix Medical |
| Owner/operator number | 10095287 |
| Product codes | KMK |
| Device names | KMK - Device, Intravascular Catheter Securement |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5210 |
| Review panels | General Hospital |
| Registered establishments | Affix Medical - mHUB Facility |
| Establishment registrations | 3043354155 |
| FEI numbers | 3043354155 |
| Establishment operations | Specification Developer |
| 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