Penlon
Catalogue number A200SP, listed by Penlon 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
1510(k) clearance
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 | Penlon Ltd., United Kingdom |
|---|---|
| FDA product code | BSF |
| Device type | Absorber, Carbon-Dioxide |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5310 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-03-30 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A200SP | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K801255 | 1980-06-04 |
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.