Assura
Assura Irrigation Set. 1 Water bag, 1 Irrigation cone, 1 Belt plate, 2 Irrigation Sleeves
2manufacturers in China registered for this device type
6catalogue 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 |
| Record published | 2016-09-14 |
| Record revised | 2024-04-17 (version 3) |
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 |
| Storage | Special storage condition: Keep away from sunlight. |
| Packaging | Shipper box of 20, shipper box of 12, retail box of 5, shipper box of 10 |
| Sizes | Lumen/inner diameter 40 to 60 mm |
| Distribution end date | 2016-09-22 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 12836 | Lumen/Inner Diameter 60 mm | 5 | In distribution |
| 12834 | Lumen/Inner Diameter 40 mm | 5 | In distribution |
| 12820 | In distribution | ||
| 12830 | In distribution | ||
| 12835 | Lumen/Inner Diameter 50 mm | 5 | In distribution |
| 12830 | Withdrawn |
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 |
| 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 |
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.