FDA device listing
Foley Catheter with AquaFil,Foley Catheter with Syringe,I.C. Foley Catheter AquaFil,I.C. Foley Catheter with Urine…
FDA device listing 1444960372 · C. R. Bard, Inc.
Key facts
| Proprietary names | Foley Catheter with AquaFil,Foley Catheter with Syringe,I.C. Foley Catheter AquaFil,I.C. Foley Catheter with Urine Collection Container,Lubri-Sil I.C. Complete Care Urine Meter Foley Tray (for Canada),Magic3 Touchless Hydrophilic Intermittent Catheter System (for Canada),SureStep Foley Tray System Bardex I.C. Complete Care Foley Catheter (for Canada),SureStep Foley Tray System Bardex IC Complete… |
|---|---|
| Owner/operator | C. R. Bard, Inc. |
| Owner/operator number | 2212754 |
| Product codes | MJC |
| Device names | MJC - Catheter, Urological (Antimicrobial) And Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5130 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | BARD SDN. BHD., C.R. BARD, INC., PRODUCTOS PARA EL CUIDADO DE LA SALUD |
| Establishment registrations | 1018233, 8040607, 9611590, 3006082230 |
| FEI numbers | 1018233, 1000237915, 3002806591, 3006082230 |
| Establishment operations | Contract Manufacturer, Repackager/Relabeler, Contract Sterilizer, 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