Catheter and Glove Suction Kit
Catheter and Glove Suction Kit with Solution Container, CSR Wrap and Two Vinyl Gloves
93manufacturers in China registered for this device type
8catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (29), Guangdong (28), Jiangsu (17). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
Showing 12 of 93. All 93 manufacturers in China registered for Catheters, Suction, Tracheobronchial
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | BSY |
| Device type | Catheters, Suction, Tracheobronchial |
| Device class | Class 1 |
| Regulation | 21 CFR 868.6810 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-21 |
| Record revised | 2022-05-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50 |
| Sizes | Length 16 to 22 in; catheter gauge 5 to 18 Fr |
| Distribution end date | 2022-05-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0140070 | Length 16 in | Withdrawn |
| 0140100 | Length 18 in | Withdrawn |
| 0140080 | Length 16 in | Withdrawn |
| 0140040 | Length 22 in | Withdrawn |
| 0140090 | Length 18 in | Withdrawn |
| 0140110 | Catheter Gauge 18 Fr | Withdrawn |
| 0140060 | Length 22 in | Withdrawn |
| 0140050 | Catheter Gauge 14 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ballard™ | SunMed Group Holdings, LLC | 214 |
| Res-Q-Vac | Repro-Med Systems, Inc. | 201 |
| DAR | Covidien LP | 185 |
| Ballard* Closed Suction System for Adults | Avanos Medical, Inc. | 108 |
| Suction Catheter | Well Lead Medical Co., Ltd. | 97 |
| Avanos | Avanos Medical, Inc. | 63 |
| Ballard* Closed Suction System | Avanos Medical, Inc. | 57 |
| Ballard* Turbo-Cleaning Closed Suction System | Avanos Medical, Inc. | 57 |
| Medline | Medline Industries, Inc. | 49 |
| ProCure | Twin Med, LLC | 47 |
| AirLife™ | Airlife, Inc. | 44 |
| Closed Suction Catheters | Ningbo Xinwell Medical Technology Co., Ltd. | 38 |
Showing 12 of 147. All products under Catheters, Suction, Tracheobronchial
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-09-28 | Not classified | Other | Varying degrees of difficulty were encountered when opening and closing the InnoValve. | 10169 units | 2006-01-25 |
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.