Navina™ Smart System Regular
Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube set, 2 Rectal catheters regular, 1 Accessory set, 1 Navina case. Non Sterile Device. Rx Only.
24manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (11), Guangdong (5), Zhejiang (4). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Ningbo Just Soon Industrial Limited | Ningbo | Zhejiang | Repacker / relabeller | 36 |
Showing 12 of 24. All 24 manufacturers in China registered for Enema Kit
Record
| Listed by | Wellspect Healthcare, Sweden |
|---|---|
| FDA product code | FCE |
| Device type | Enema Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5210 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2019-12-19 |
| Record revised | 2024-06-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a dry place at room temperature. |
| Distribution end date | 2023-10-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 69009 | In distribution | |
| 69009 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health | 10 |
| Cephus Catheter | Sealcath, LLC | 5 |
| Dover | Cardinal Health 200, LLC | 4 |
| LSL Healthcare | Lsl Industries, Inc. | 3 |
| Health Care Logistics, Inc® | Health Care Logistics, Inc. | 2 |
| Navina™ Classic System Cone Refill | Wellspect Healthcare | 2 |
| Premium | Ningbo Albert Novosino Co., Ltd. | 2 |
| Navina™Consumable Set Cone | Wellspect Healthcare | 2 |
| Navina™ Smart System Small | Wellspect Healthcare | 2 |
| Navina™ Classic System Small Refill | Wellspect Healthcare | 2 |
| Navina™ Classic System Small | Wellspect Healthcare | 1 |
| AMSure® Cleansing Enema Bucket Set | Amsino Medical Inc. | 1 |
Showing 12 of 29. All products under Enema Kit
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.