FDA device listing
Bag, Urine Collection, Leg, For External Use, Non-Sterile
FDA device listing 1397163144 · ANSELL HEALTHCARE PRODUCTS LLC
Key facts
| Owner/operator | ANSELL HEALTHCARE PRODUCTS LLC |
|---|---|
| Owner/operator number | 8020065 |
| Product codes | NNW |
| Device names | NNW - Bag, Urine Collection, Leg, For External Use, Non-Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5250 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | ANSELL HEALTHCARE PRODUCTS LLC, Ansell Sandel Medical Solutions LLC |
| Establishment registrations | 3004125670, 3011209798 |
| FEI numbers | 3004125670, 3011209798 |
| Establishment operations | Manufacturer, 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