CO2 Absorber Disposable, 12 Pcs
Catalogue number 6677845, listed by Maquet Critical Care AB, Sweden, under Absorber, Carbon-Dioxide. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Shandong Jinlai Huanhai Medical Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 19 |
| Jiangsu Haize Medical Scientific Development Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 9 |
Record
| Listed by | Maquet Critical Care AB, Sweden |
|---|---|
| FDA product code | BSF |
| Device type | Absorber, Carbon-Dioxide |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5310 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-10-22 |
| Record revised | 2018-03-29 (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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6677845 | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AincA® | Anesthesia Associates, Inc. | 3 |
| Aria | Molecular Products Ltd | 3 |
| Column, Ascarite, Desiccator, Disposable | A-M Systems | 3 |
| Absorber, Carbon-Dioxide | Datex-Ohmeda, Inc. | 2 |
| Column, Desiccator, Disposable, 7 In | A-M Systems | 2 |
| Sodasorb® | Molecular Products Ltd | 1 |
| Absorbent, C02, Sodalime | A-M Systems | 1 |
| Sofnolime® | Molecular Products Ltd | 1 |
| Abcan, Spherasorb™ Disposable CO2 Absorber, White TO Violet Colour Change, 1.1L | Intersurgical Ltd. | 1 |
| Absorbent, CO2, Carbolime | A-M Systems | 1 |
| Abcan, Loflosorb™ Disposable CO2 Absorber, Green TO Violet Colour Change, 1.1L | Intersurgical Ltd. | 1 |
| Pyramid Mkii Loflosorb G/V | Intersurgical Ltd. | 1 |
Showing 12 of 33. All products under Absorber, Carbon-Dioxide
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 | Closed |
|---|---|---|---|---|---|---|---|
| Getinge US Sales LLC | UDI-DI | 2019-07-22 | Class II | Under Investigation by firm | Reversed expiration and manufacturing date on the label | 1444 boxes worldwide | 2020-05-26 |
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.