SenSura Mio
2 catalogue numbers from 11754, listed by Coloplast A/S, Denmark, under Irrigator, Ostomy. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Hunan (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Cofoe Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 22 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
Record
| Listed by | Coloplast A/S, Denmark |
|---|---|
| FDA product code | EXD |
| Device type | Irrigator, Ostomy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5895 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Shipper box of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 11754 | In distribution | ||
| 11750 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MiniACE | Applied Medical Technology, Inc. | 90 |
| MiniACE™ Low Profile Antegrade Continence Enema Button | Applied Medical Technology, Inc. | 30 |
| Assura | Coloplast A/S | 6 |
| Coloplast | Coloplast A/S | 5 |
| SUR-FIT Natura | Convatec, Purchasing Department | 4 |
| Hollister | Hollister Incorporated | 4 |
| New Image | Hollister Incorporated | 3 |
| Visi-Flow Natura Irrigator W/Cone | Convatec, Purchasing Department | 1 |
| Visi-Flow Stoma Cone | Convatec, Purchasing Department | 1 |
| Visiflow Natura Irrig KIT 70MM | Convatec, Purchasing Department | 1 |
| Visiflow Natura Irrig KIT 45MM | Convatec, Purchasing Department | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121833 | 2012-07-16 |
| K840268 | 1984-04-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.