MiniACE™ Low Profile Antegrade Continence Enema Button
MiniACE™ Low Profile Antegrade Continence Enema Button with Enfit® - 12F x 2.3cm
2manufacturers in China registered for this device type
30catalogue 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 | Applied Medical Technology, Inc., United States |
|---|---|
| FDA product code | EXD |
| Device type | Irrigator, Ostomy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5895 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K180026 |
| Record published | 2018-07-02 |
| Record revised | 2020-08-07 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 0.8 to 8 cm; catheter gauge 12 to 14 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACE-1223-I | Length 2.3 cm | In distribution |
| ACE-1235 | Length 3.5 cm | In distribution |
| ACE-1212-I | Length 1.2 cm | In distribution |
| ACE-1450-I | Length 5.0 cm | In distribution |
| ACE-1427-I | Length 2.7 cm | In distribution |
| ACE-1470-I | Length 7.0 cm | In distribution |
| ACE-1225 | Length 2.5 cm | In distribution |
| ACE-1408 | Length 0.8 cm | In distribution |
| ACE-1420-I | Length 2.0 cm | In distribution |
| ACE-1444-I | Length 4.4 cm | In distribution |
| ACE-1435-I | Length 3.5 cm | In distribution |
| ACE-1480 | Length 8.0 cm | In distribution |
| ACE-1410 | Length 1.0 cm | In distribution |
| ACE-1220 | Length 2.0 cm | In distribution |
| ACE-1455 | Length 5.5 cm | In distribution |
| ACE-1227 | Length 2.7 cm | In distribution |
| ACE-1240-I | Length 4.0 cm | In distribution |
| ACE-1425 | Length 2.5 cm | In distribution |
| ACE-1215 | Length 1.5 cm | In distribution |
| ACE-1465 | Length 6.5 cm | In distribution |
| ACE-1210 | Length 1 cm | In distribution |
| ACE-1430 | Length 3.0 cm | In distribution |
| ACE-1217-I | Length 1.7 cm | In distribution |
| ACE-1230-I | Length 3.0 cm | In distribution |
| ACE-1460-I | Length 6.0 cm | In distribution |
| ACE-1423 | Length 2.3 cm | In distribution |
| ACE-1412-I | Length 1.2 cm | In distribution |
| ACE-1440 | Length 4.0 cm | In distribution |
| ACE-1417 | Length 1.7 cm | In distribution |
| ACE-1415-I | Length 1.5 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MiniACE | Applied Medical Technology, Inc. | 90 |
| 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 |
| 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.