Ballard™
BALLARD™ SINGLE DOSE VIALS For Airway Lavage and Closed Suction Catheter Cleaning • Pink Vials • 0.9% Sodium Chloride Solution
93manufacturers in China registered for this device type
214catalogue numbers in this listing
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 | SunMed Group Holdings, LLC, United States |
|---|---|
| FDA product code | BSY |
| Device type | Catheters, Suction, Tracheobronchial |
| Device class | Class 1 |
| Regulation | 21 CFR 868.6810 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-11-18 |
| Record revised | 2026-07-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 2, dispenser of 10, case of 10, case of 20, case of 50, case of 5 |
| Sizes | Catheter gauge 5 to 16 Fr; length 15 to 22 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 201 | Catheter Gauge 5 Fr | In distribution | |
| 19000 | In distribution | ||
| 8314 | Catheter Gauge 10 Fr | In distribution | |
| 114 | In distribution | ||
| 196-5 | Catheter Gauge 6 Fr | In distribution | |
| 2160-4J | Catheter Gauge 12 Fr | In distribution | |
| 2210 | Catheter Gauge 14 Fr | In distribution | |
| 22703-5 | Catheter Gauge 14 Fr | In distribution | |
| 2271013-4J | In distribution | ||
| 112 | In distribution | ||
| 113 | Length 22 mm | In distribution | |
| 22056 | Catheter Gauge 14 Fr | In distribution | |
| 22701356-5 | Catheter Gauge 14 Fr | In distribution | |
| 8295J | Catheter Gauge 6 Fr | In distribution | |
| 22716 | In distribution | ||
| 1940 | Catheter Gauge 5 Fr | In distribution | |
| 2271418-5 | Catheter Gauge 14 Fr | In distribution | |
| 22059 | In distribution | ||
| 8317 | In distribution | ||
| 208-4J | Catheter Gauge 8 Fr | In distribution | |
| 22108-5 | Catheter Gauge 14 Fr | In distribution | |
| 2260 | Catheter Gauge 16 Fr | In distribution | |
| 21603-5 | Catheter Gauge 12 Fr | In distribution | |
| 216-5 | In distribution | ||
| 196 | Catheter Gauge 6 Fr | In distribution | |
| 2105-S | Catheter Gauge 10 Fr | In distribution | |
| 2255 | Catheter Gauge 16 Fr | In distribution | |
| 2205 | Catheter Gauge 14 Fr | In distribution | |
| 227105-5 | In distribution | ||
| 2123 | In distribution | ||
| 221038 | Catheter Gauge 14 Fr | In distribution | |
| 2201358 | In distribution | ||
| 206 | Catheter Gauge 6 Fr | In distribution | |
| 22714186-5 | Catheter Gauge 14 Fr | In distribution | |
| 2276-5 | Catheter Gauge 14 Fr | In distribution | |
| 220135 | Catheter Gauge 14 Fr | In distribution | |
| 197-4J | In distribution | ||
| 25-2210-5 | In distribution | ||
| 22714186 | In distribution | ||
| 01-EC-459-1205 | In distribution | ||
| 227036 | In distribution | ||
| 221036 | Catheter Gauge 14 Fr | In distribution | |
| 22701356 | In distribution | ||
| 22703-4J | In distribution | ||
| 226-5 | In distribution | ||
| 22106-4J | Catheter Gauge 14 Fr | In distribution | |
| 2155-5 | In distribution | ||
| 22715-5 | In distribution | ||
| 227 | In distribution | ||
| 2205-5 | Catheter Gauge 14 Fr | In distribution | |
| 01-EC-254-1201 | In distribution | ||
| 2255-S | Catheter Gauge 16 Fr | In distribution | |
| 8313 | Catheter Gauge 8 Fr | In distribution | |
| 111 | In distribution | ||
| 215135 | Catheter Gauge 12 Fr | In distribution | |
| 2271418 | In distribution | ||
| 215120-5 | In distribution | ||
| 22056-5 | In distribution | ||
| 8213 | Catheter Gauge 8 Fr | In distribution | |
| 197 | Catheter Gauge 7 Fr | In distribution | |
| 22705 | In distribution | ||
| 8309 | Catheter Gauge 14 Fr | In distribution | |
| 22716-4J | In distribution | ||
| 221036-4J | Catheter Gauge 14 Fr | In distribution | |
| 22025 | Catheter Gauge 14 Fr | In distribution | |
| 1920 | Catheter Gauge 5 Fr | In distribution | |
| 2260-5 | In distribution | ||
| 227105 | In distribution | ||
| 1968127 | Catheter Gauge 6 Fr | In distribution | |
| 227036-5 | Catheter Gauge 14 Fr | In distribution | |
| 2-030 | In distribution | ||
| 2143 | In distribution | ||
| 2205-S | Catheter Gauge 14 Fr | In distribution | |
| 2276 | In distribution | ||
| 22108147 | Catheter Gauge 14 Fr | In distribution | |
| 8155 | In distribution | ||
| 216036-5 | Catheter Gauge 12 Fr | In distribution | |
| 22113 | Catheter Gauge 14 Fr | In distribution | |
| 01-EC-350-0001 | In distribution | ||
| 12606 | In distribution | ||
| 221-5 | In distribution | ||
| 2270156-5 | Catheter Gauge 14 Fr | In distribution | |
| 01-EC-254-1205 | In distribution | ||
| 227156-5 | In distribution | ||
| 195 | Catheter Gauge 5 Fr | In distribution | |
| 1910 | Catheter Gauge 10 Fr | In distribution | |
| 227135 | In distribution | ||
| 118 | In distribution | ||
| 210 | Catheter Gauge 10 Fr | In distribution | |
| 2271613-5 | In distribution | ||
| 1912-5 | Catheter Gauge 12 Fr | In distribution | |
| 208-5 | Catheter Gauge 8 Fr | In distribution | |
| 2151235-5 | Catheter Gauge 12 Fr | In distribution | |
| 2210-4J | Catheter Gauge 14 Fr | In distribution | |
| 22015 | Catheter Gauge 14 Fr | In distribution | |
| 20083 | Catheter Gauge 8 Fr | In distribution | |
| 1988128 | Catheter Gauge 8 Fr | In distribution | |
| 2-025 | In distribution | ||
| 21606-5 | Catheter Gauge 12 Fr | In distribution | |
| 22714183-5 | Catheter Gauge 14 Fr | In distribution | |
| 8293J | Catheter Gauge 5 Fr | In distribution | |
| 2270135 | In distribution | ||
| 21513511 | Catheter Gauge 12 Fr | In distribution | |
| 198 | Catheter Gauge 8 Fr | In distribution | |
| 22712186-5 | Catheter Gauge 12 Fr | In distribution | |
| 205-5 | In distribution | ||
| 116 | In distribution | ||
| 22715 | In distribution | ||
| 22716036-5 | Catheter Gauge 12 Fr | In distribution | |
| 210-4J | Catheter Gauge 10 Fr | In distribution | |
| 2-020 | In distribution | ||
| 22113-5 | In distribution | ||
| 198-4J | In distribution | ||
| 2105 | Catheter Gauge 10 Fr | In distribution | |
| 2273 | In distribution | ||
| 22058 | Catheter Gauge 14 Fr | In distribution | |
| 2271603-5 | Catheter Gauge 12 Fr | In distribution | |
| 200-5 | In distribution | ||
| 210-5 | Catheter Gauge 10 Fr | In distribution | |
| 2271618-5 | In distribution | ||
| 220568-5 | In distribution | ||
| 01-EC-256-1201 | In distribution | ||
| 2271516-5 | In distribution | ||
| 22606-5 | In distribution | ||
| 22716-5 | Catheter Gauge 12 Fr | In distribution | |
| 123 | 10 | In distribution | |
| 22103 | Catheter Gauge 14 Fr | In distribution | |
| 2271603 | In distribution | ||
| 2271616-5 | In distribution | ||
| 227-5 | Catheter Gauge 14 Fr | In distribution | |
| 22714183 | In distribution | ||
| 2160-5 | Catheter Gauge 12 Fr | In distribution | |
| 220125-5 | Catheter Gauge 14 Fr | In distribution | |
| 8308 | Catheter Gauge 14 Fr | In distribution | |
| 227141863-5 | Catheter Gauge 14 Fr | In distribution | |
| 21559 | In distribution | ||
| 2255-5 | In distribution | ||
| 2155 | Catheter Gauge 12 Fr | In distribution | |
| 21606-4J | Catheter Gauge 12 Fr | In distribution | |
| 195-5 | Catheter Gauge 5 Fr | In distribution | |
| 22703 | In distribution | ||
| 227161863-5 | In distribution | ||
| 216036-4J | Catheter Gauge 12 Fr | In distribution | |
| 215125-5 | Catheter Gauge 12 Fr | In distribution | |
| 22712183 | Catheter Gauge 12 Fr | In distribution | |
| 227012586 | In distribution | ||
| 2271013 | In distribution | ||
| 21603-4J | Catheter Gauge 12 Fr | In distribution | |
| 227101-5 | In distribution | ||
| 2-040 | In distribution | ||
| 22109 | In distribution | ||
| 01-EC-256-1205 | In distribution | ||
| 206-5 | Catheter Gauge 6 Fr | In distribution | |
| 227161 | In distribution | ||
| 8169 | Catheter Gauge 14 Fr | In distribution | |
| 227056 | In distribution | ||
| 1900 | Catheter Gauge 5 Fr | In distribution | |
| 207-5 | Catheter Gauge 7 Fr | In distribution | |
| 200 | Catheter Gauge 6 Fr | In distribution | |
| 22556 | Catheter Gauge 16 Fr | In distribution | |
| 22108 | Catheter Gauge 14 Fr | In distribution | |
| 2155-S | Catheter Gauge 12 Fr | In distribution | |
| 22012356-5 | In distribution | ||
| 207-4J | Catheter Gauge 7 Fr | In distribution | |
| 205 | Catheter Gauge 8 Fr | In distribution | |
| 2201258 | Catheter Gauge 14 Fr | In distribution | |
| 22106-5 | Catheter Gauge 14 Fr | In distribution | |
| 2271053-5 | In distribution | ||
| 2271018-5 | In distribution | ||
| 227135-5 | In distribution | ||
| 1978127 | Catheter Gauge 7 Fr | In distribution | |
| 2-035 | In distribution | ||
| 227165 | In distribution | ||
| 2271603-4J | In distribution | ||
| 1910-5 | Catheter Gauge 10 Fr | In distribution | |
| 01-EC-459-1201 | In distribution | ||
| 208 | Catheter Gauge 8 Fr | In distribution | |
| 2271218-5 | Catheter Gauge 12 Fr | In distribution | |
| 220135-5 | In distribution | ||
| 206-4J | Catheter Gauge 6 Fr | In distribution | |
| 8215 | Catheter Gauge 10 Fr | In distribution | |
| 01-EC-200-2200 | In distribution | ||
| 22716183-5 | In distribution | ||
| 227161-5 | In distribution | ||
| 2210-5 | Catheter Gauge 14 Fr | In distribution | |
| 221036-5 | Catheter Gauge 14 Fr | In distribution | |
| 1115 | Length 15 mm | In distribution | |
| 197-5 | Catheter Gauge 7 Fr | In distribution | |
| 2160 | Catheter Gauge 12 Fr | In distribution | |
| 1900J | Catheter Gauge 5 Fr | In distribution | |
| 198-5 | Catheter Gauge 8 Fr | In distribution | |
| 22103-4J | Catheter Gauge 14 Fr | In distribution | |
| 21603 | Catheter Gauge 12 Fr | In distribution | |
| 01-EC-459-1401 | In distribution | ||
| 1912 | Catheter Gauge 12 Fr | In distribution | |
| 227121863-5 | Catheter Gauge 12 Fr | In distribution | |
| 195-4J | In distribution | ||
| 119 | In distribution | ||
| 22106 | Catheter Gauge 14 Fr | In distribution | |
| 2-045 | In distribution | ||
| 221 | Catheter Gauge 14 Fr | In distribution | |
| 227101-4J | In distribution | ||
| 8294J | Catheter Gauge 8 Fr | In distribution | |
| 22716186-5 | In distribution | ||
| 01-EC-459-1405 | In distribution | ||
| 202 | Catheter Gauge 5 Fr | In distribution | |
| 207 | Catheter Gauge 7 Fr | In distribution | |
| 01-EC-200-2205 | In distribution | ||
| 227-4J | In distribution | ||
| 216 | Catheter Gauge 12 Fr | In distribution | |
| 227166-5 | Catheter Gauge 12 Fr | In distribution | |
| 22103-5 | Catheter Gauge 14 Fr | In distribution | |
| 2103 | Catheter Gauge 10 Fr | In distribution | |
| 196-4J | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| RespVac™ | Cutting Edge HC Brands LLC | 26 |
Showing 12 of 147. All products under Catheters, Suction, Tracheobronchial
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Avanos Medical, Inc. | UDI-DI | 2023-10-13 | Class II | Labeling Change Control | Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP. | 4730 cases (94600 devices) |
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.