FDA device listing
DIAMONDS Gelling and Odour Control Sachets,ESENTA Lubricating Deodorant,Visi-Flow Irrigation Sleeve
FDA device listing 1164774439 · ConvaTec
Key facts
| Proprietary names | DIAMONDS Gelling and Odour Control Sachets,ESENTA Lubricating Deodorant,Visi-Flow Irrigation Sleeve |
|---|---|
| Owner/operator | ConvaTec |
| Owner/operator number | 2241599 |
| Product codes | EXB |
| Device names | EXB - Collector, Ostomy |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | CONVATEC DOMINICAN REPUBLIC, INC., ConvaTec, Inc., CONVATEC LIMITED |
| Establishment registrations | 9618003, 1000317571, 3011987967 |
| FEI numbers | 1000317571, 3003264198, 3011987967 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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