Dover
Flatus Bag with Rectal Tube,Pre-Lubricated Tip
24manufacturers in China registered for this device type
10catalogue 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 | Cardinal Health, United States |
|---|---|
| FDA product code | FCE |
| Device type | Enema Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5210 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-06-29 |
| Record revised | 2025-12-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT |
| Packaging | Case of 50 |
| Sizes | Length 19 to 60 in; catheter gauge 18 to 24 Fr; total volume 1400 ml |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 155731 | Catheter Gauge 24 Fr | In distribution |
| 145546 | Total Volume 1400 ml | In distribution |
| 145540 | Length 60 in | In distribution |
| 155731 | Length 20 in | In distribution |
| 155730 | Length 20 in | In distribution |
| 145541 | Catheter Gauge 24 Fr | Withdrawn |
| 145524 | Catheter Gauge 24 Fr | Withdrawn |
| 145541 | Length 60 in | Withdrawn |
| 155733 | Length 60 in | Withdrawn |
| 145524 | Catheter Gauge 24 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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™ Smart System Regular | Wellspect Healthcare | 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.