Amsorb® Plus
AMAB40001GE - 2105489-011 Amsorb Plus Bubble-CAN Universal 1.2L.
4manufacturers in China registered for this device type
13catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (2), Shandong (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Shandong Jinlai Huanhai Medical Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 19 |
| Excellentcare Medical (Huizhou) Ltd. | Huizhou | Guangdong | Manufacturer | 14 |
| Jianshi Biotechnology (Zhejiang) Co., Ltd. | Yuyao | Zhejiang | Manufacturer | 6 |
Record
| Listed by | Armstrong Medical Ltd., United Kingdom |
|---|---|
| FDA product code | CBL |
| Device type | Absorbent, Carbon-Dioxide |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5300 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-08-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AMAB4001 | In distribution | |
| AMAB3200 | In distribution | |
| AMAB3801GE | In distribution | |
| AMAB3000 | In distribution | |
| AMAB3201GE | In distribution | |
| AMAB3803GE | In distribution | |
| AMAB3803 | In distribution | |
| AMAB3800 | In distribution | |
| AMAB3201 | In distribution | |
| AMAB3000GE | In distribution | |
| AMAB4001GE | In distribution | |
| AMAB3801 | In distribution | |
| AMAB3400 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atrasorb | Atrasorb Industria DE Produtos Hospitalares Ltda | 45 |
| PC | Allied Medical LLC | 18 |
| Medisorb™ | AirLife Finland Oy | 11 |
| Sofnolime® | Molecular Products Ltd | 5 |
| Sodasorb® | Molecular Products Ltd | 4 |
| SpiraLith Ca | Micropore Inc | 4 |
| Xenon Master | Medi Nuclear Corp., Inc. | 3 |
| Absorbent, Carbon-Dioxide | Medi Nuclear Corp., Inc. | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Sodasorb® Hmed, 4-8, W-V Indicating, Canister Pak (12 bags/box) | Molecular Products Ltd | 2 |
| Sodasorb® Hmed, 4-8, W-V Indicating, Individual Canister Pak, U-RAE | Molecular Products Ltd | 2 |
| Sodasorb® Hmed, 4-8, W-V Indicating, Individual Canister Pak | Molecular Products US Holdings, Inc. | 2 |
Showing 12 of 31. All products under Absorbent, Carbon-Dioxide
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-08-05 | Class I | Nonconforming Material/Component | Some devices may be associated with high and unexpected resistance to gas flow during clinical use, impacting or preventing adequate ventilation of an anaesthetised patient, which could cause a delay in treatment. Not all defective canister | 214,032 boxes | 2024-09-17 |
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.