Hollister
Stoma Cone Irrigator Kit
2manufacturers in China registered for this device type
4catalogue numbers in this listing
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 | Hollister Incorporated, United States |
|---|---|
| FDA product code | EXD |
| Device type | Irrigator, Ostomy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5895 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2022-11-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Cas of 12, cas of 24 |
| Sizes | Lumen/inner diameter 51 to 76 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 7721 | In distribution | ||
| 7728 | Lumen/Inner Diameter 51 mm | 20 | In distribution |
| 7723 | 10 | In distribution | |
| 7724 | Lumen/Inner Diameter 76 mm | 20 | 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 |
| New Image | Hollister Incorporated | 3 |
| SenSura Mio | Coloplast A/S | 2 |
| 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 |
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.