FDA device listing
FitRight ActivEdge Bladder Control Pads,FitRight ActivEdge Male Guard,FitRight ActivEdge Underwear,FitRight Booster…
FDA device listing 1379400928 · Medline Industries, LP
Key facts
| Proprietary names | FitRight ActivEdge Bladder Control Pads,FitRight ActivEdge Male Guard,FitRight ActivEdge Underwear,FitRight Booster Pad,FitRight Cloth-Like Adult Incontinence Briefs,FitRight EasyFlex Brief,FitRight Extended Wear Underwear,FitRight Underwear,Medline Belted Briefs,Medline Maternity Knit Underpants,Medline Mesh Underpants |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Product codes | EYQ |
| Device names | EYQ - Garment, Protective, For Incontinence |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5920 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Medline Canada, Medline Industries, LP - Lithia Springs, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - Northfield, PRODUCTOS MEDLINE S.A. DE C.V. |
| Establishment registrations | 1417592, 1000110779, 3004122598, 3007289408, 3015173212 |
| FEI numbers | 1417592, 1000110779, 3004122598, 3007289408, 3015173212 |
| Establishment operations | Foreign Exporter, Manufacturer, Repackager/Relabeler, 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