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EZ-IO Training Power Driver - FOR Training Purposes Only
20manufacturers in China registered for this device type
2catalogue numbers in this listing
7recalls 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 | Teleflex Medical LLC, United States |
|---|---|
| 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 |
| Premarket notification | Exempt |
| Record published | 2022-12-05 |
| Record revised | 2025-04-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Packaging | Case |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN915666 | In distribution | |
| IPN035978 | 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)
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2018-03-27 | Class II | Device Design | These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient. | 103910 units | 2021-05-04 |
| 2009-12-02 | Not classified | Packaging | Products 1664 and 1665 are each one-way valves that offer low flow resistance, each in one, opposite direction. Each of these valves demonstrate the appropriate direction with a red arrow. The reason for this recall is incorrect packaging | 2450 eaches | 2010-08-11 |
| 2009-07-31 | Not classified | Process control | The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient’s lungs. | 569,465 (total for all types) | 2011-09-15 |
| 2009-07-31 | Not classified | Process control | The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient’s lungs. | 569,465 (total for all types) | 2011-09-15 |
| 2009-07-31 | Not classified | Process control | The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient’s lungs. | 569,465 (total for all types) | 2011-09-15 |
| 2009-07-31 | Not classified | Process control | The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient’s lungs. | 569,465 eaches (total for all types) | 2011-09-15 |
| 2009-07-31 | Not classified | Process control | The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient’s lungs. | 569,465 (total for all types) | 2011-09-15 |
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.