Sofnolime®
Sofnolime® 2550, W-V Indicating, Canister Pak (12 bags/box) MPI-Medline
4manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
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 | Molecular Products Ltd, United Kingdom |
|---|---|
| FDA product code | CBL |
| Device type | Absorbent, Carbon-Dioxide |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5300 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 0 to 35 °C |
| Packaging | Box of 2, box of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CD02-0053 | In distribution | |
| CD02-0056 | In distribution | |
| CD02-0054 | In distribution | |
| CD02-0057 | In distribution | |
| CD02-0058 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atrasorb | Atrasorb Industria DE Produtos Hospitalares Ltda | 45 |
| PC | Allied Medical LLC | 18 |
| Amsorb® Plus | Armstrong Medical Ltd. | 13 |
| Medisorb™ | AirLife Finland Oy | 11 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K921803 | 1992-10-15 |
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.