FDA device listing
UDM-10 Urinary Drainage Monitoring,Urinary drainage collection kit, for in-dwelling catheter
FDA device listing 1118659838 · C. R. Bard, Inc.
Key facts
| Proprietary names | UDM-10 Urinary Drainage Monitoring,Urinary drainage collection kit, for in-dwelling catheter |
|---|---|
| Owner/operator | C. R. Bard, Inc. |
| Owner/operator number | 2212754 |
| Product codes | FCN |
| Device names | FCN - Urinary Drainage Collection Kit, For Indwelling Catheter |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5250 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Bard Access Systems, Inc., C.R. BARD, INC. |
| Establishment registrations | 1018233, 3006082230, 3006260740 |
| FEI numbers | 1018233, 3006082230, 3006260740 |
| Establishment operations | Complaint File Establishment, 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