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2-Piece Ostomy Irrigator Sleeve
2manufacturers in China registered for this device type
3catalogue 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 | 2022-12-01 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Cas of 24 |
| Sizes | Lumen/inner diameter 44 to 70 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 18152 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 18153 | Lumen/Inner Diameter 57 mm | 5 | In distribution |
| 18154 | Lumen/Inner Diameter 70 mm | 5 | 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 |
| 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.