BD BBL™ Bio-Bag™ Environmental Chamber Type A, Multi-Plate
Bag Bio-Bag Type A Multi-Plate 50 Ea
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 | 2022-11-18 (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 15 to 30 °C |
| Distribution end date | 2021-09-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 261216 | 50 | Withdrawn |
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 |
| Advanced Instruments Palladox Disposable Satchet | Advanced Instruments, LLC | 1 |
| BD BBL™ GasPak™ 100 Anaerobic System, Vented | Becton, Dickinson AND Company | 1 |
| BD BBL™ GasPak™ 150 Large Anaerobic System, Vented | Becton, Dickinson AND Company | 1 |
Showing 12 of 48. All products under Device, Gas Generating
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.