BD GasPak™ EZ CO2 Gas Generating Pouch System
Catalogue number 260684, listed by Becton, Dickinson AND Company, United States, under Device, Gas Generating. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | KZJ |
| Device type | Device, Gas Generating |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2580 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-25 |
| Record revised | 2024-07-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 260684 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BD BBL™ Bio-Bag™ Environmental Chamber Type A | Becton, Dickinson AND Company | 2 |
| BD BBL™ Bio-Bag™ Environmental Chamber Type C | Becton, Dickinson AND Company | 2 |
| BD BBL™ GasPak™ 150 Large Anaerobic System | Becton, Dickinson AND Company | 1 |
| BD GasPak™ EZ CO2 Container System Sachets | Becton, Dickinson AND Company | 1 |
| BD GasPak™ EZ Anaerobe Container System Sachets | Becton, Dickinson AND Company | 1 |
| Campygen (2.5 Litres) | Oxoid, Ltd. | 1 |
| BD BBL™ CO2 Indicators | Becton, Dickinson AND Company | 1 |
| Advanced Instruments Standard Anoxomat Jar, Large | Advanced Instruments, LLC | 1 |
| Advanced Instruments Standard Anoxomat Jar, Small | Advanced Instruments, LLC | 1 |
| BD BBL™ Bio-Bag™ Environmental Chamber Type A, Multi-Plate | Becton, Dickinson AND Company | 1 |
| Advanced Instruments Palladox Disposable Satchet | Advanced Instruments, LLC | 1 |
| BD BBL™ GasPak™ 100 Anaerobic System, Vented | Becton, Dickinson AND Company | 1 |
Showing 12 of 48. All products under Device, Gas Generating
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 |
|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | UDI-DI | 2026-04-07 | Class II | Under Investigation by firm | BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification. | 25,760 units |
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.