Pyramid Mkii Loflosorb G/V
Catalogue number 2193001, listed by Intersurgical Ltd., United Kingdom, under Absorber, Carbon-Dioxide. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
1recall
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 | Intersurgical Ltd., United Kingdom |
|---|---|
| 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 | 2021-10-28 |
| Record revised | 2025-02-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2193001 | 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: Soda Lime Absorber Sherasorb W/V | Intersurgical Ltd. | 1 |
Showing 12 of 33. All products under Absorber, Carbon-Dioxide
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-02-09 | Not classified | Device Design | Intersurgical Incorporated has issued a voluntary recall of the IS Cans Carbon Dioxide Absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system. | 110 units | 2013-01-15 |
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.