Dust CAP, 22f
Catalogue number 1978000, listed by Intersurgical Ltd., United Kingdom, under Connector, Airway (Extension). 20 manufacturers in China are registered for this product code.
20manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (6), Zhejiang (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Dongguan Junhai Medical Device Co., Ltd. | Dong Guang | Guangdong | Contract manufacturer | 9 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Suzhou Yuyue Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
Showing 12 of 20. All 20 manufacturers in China registered for Connector, Airway (Extension)
Record
| Listed by | Intersurgical Ltd., United Kingdom |
|---|---|
| FDA product code | BZA |
| Device type | Connector, Airway (Extension) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5810 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-10-14 |
| Record revised | 2025-02-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 180, pack of 45 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1978000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AincA® | Anesthesia Associates, Inc. | 158 |
| Hudson RCI | Teleflex Medical LLC | 126 |
| AirLife™ | Airlife, Inc. | 66 |
| DAR | Covidien LP | 65 |
| Connector, Airway (Extension) | VBM Medizintechnik Gmbh | 58 |
| Medline Industries, Inc. | Medline Industries, Inc. | 24 |
| Connector, Airway (Extension) | Galemed Corp. | 23 |
| Vital Signs™ | AirLife Finland Oy | 22 |
| Airway Adapters | Respironics Novametrix, LLC | 19 |
| Oxygen Connector/Adapter | Sunset Healthcare Solutions, Inc. | 18 |
| Flexicare | Flexicare Medical Ltd. | 15 |
| Adaptors/Connectors | Westmed, Inc. | 15 |
Showing 12 of 279. All products under Connector, Airway (Extension)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K921511 | 1992-06-17 |
| K921512 | 1992-06-17 |
| K911425 | 1991-06-24 |
| K911421 | 1991-06-24 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-08-07 | Class II | Under Investigation by firm | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size. | 46,450 pieces | 2020-12-15 |
| 2019-08-07 | Class II | Under Investigation by firm | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size. | 50,400 pieces | 2020-12-15 |
| 2019-08-07 | Class II | Under Investigation by firm | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size. | 19,200 pieces | 2020-12-15 |
| 2019-08-07 | Class II | Under Investigation by firm | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size. | 115,200 pieces | 2020-12-15 |
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.