FDA device listing
ActiveLife CONVEX One-Piece Drainable Pouch with Durahesive,ActiveLife One-Piece Drainable Pouch with…
FDA device listing 1192756328 · ConvaTec
Key facts
| Proprietary names | ActiveLife CONVEX One-Piece Drainable Pouch with Durahesive,ActiveLife One-Piece Drainable Pouch with Durahesive,ActiveLife One-Piece Drainable Pouch with Durahesive Plus,ActiveLife One-Piece Drainable Pouch with Stomahesive,AutoLock SUR-FIT Drainable Pouch,COMBIHESIVE 2S,ESTEEM+ Drainable Pouch,ESTEEM+ Soft CONVEX,ESTEEM Synergy+ Drainable Pouch,ESTEEM SYNERGY Drainable Pouch,LITTLE ONES… |
|---|---|
| Owner/operator | ConvaTec |
| Owner/operator number | 2241599 |
| Product codes | EXH |
| Device names | EXH - Bag, Urinary, Ileostomy |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | CONVATEC DOMINICAN REPUBLIC, INC., ConvaTec, Inc., CONVATEC LIMITED, ConvaTec Limited, GDC Building, UNOMEDICAL S.R.O. |
| Establishment registrations | 9618003, 1000317571, 3005778470, 3008806809, 3011987967 |
| FEI numbers | 1000317571, 3003264198, 3005778470, 3008806809, 3011987967 |
| Establishment operations | Complaint File Establishment, Manufacturer, 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