FDA device listing
30cc Balloon w/o Catheter,5cc Balloon w/o Catheter,Bag (Leg Bag),bag/urinary drainage unit,Bard Deluxe Dispoz-A-Bag…
FDA device listing 1081840160 · C. R. Bard, Inc.
Key facts
| Proprietary names | 30cc Balloon w/o Catheter,5cc Balloon w/o Catheter,Bag (Leg Bag),bag/urinary drainage unit,Bard Deluxe Dispoz-A-Bag Drainage,Bard Foley Catheterization Tray,Bard Foley Catheterization Tray Uro-Prep Tray (for Canada),Bardia Foley Catheter Insertion,Bardia Urethral Catheter Tray,Bard Infection Control Urinary,Bard Leg Bag Holder,Bard Male External Catheter (OTC),Bard Male External Latex Disposable… |
|---|---|
| Owner/operator | C. R. Bard, Inc. |
| Owner/operator number | 2212754 |
| Product codes | KNX |
| Device names | KNX - Collector, Urine, (And Accessories) For Indwelling Catheter |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5250 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Bard European Distribution Center NV, BARD SDN. BHD., BARD SHANNON LIMITED, C.R. BARD, INC., PRODUCTOS PARA EL CUIDADO DE LA SALUD |
| Establishment registrations | 1018233, 8040607, 9611590, 3002504068, 3005636544, 3006082230 |
| FEI numbers | 1018233, 1000237915, 3002504068, 3002806591, 3005636544, 3006082230 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Manufacturer, Specification Developer, Foreign Exporter |
| 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