Arctic Sun Stat Temperature Management System
Arctic Sun Stat Temperature Management System Fill Tube
8manufacturers in China registered for this device type
1catalogue number
10510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Anhui (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Copious Intl., Inc. | Heyuan, Guangdong Province | Contract manufacturer | 11 | |
| Jiangyin Puremed | Jiangyin | Jiangsu | Contract manufacturer | 7 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Shanghai Xodus Medical Company Limited | Shanghai | Shanghai | Specification developer | 25 |
| Hangzhou Tappa Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 3 |
| Jiangmen Dacheng Medical Equipment Co., Ltd. | Jiangmen | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Medivance, Inc., United States |
|---|---|
| FDA product code | DWJ |
| Device type | System, Thermal Regulating |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5900 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2024-08-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -30 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mistral-Air | The Surgical Company International B.V. | 114 |
| Bair Hugger™ | 3M Company | 99 |
| IOB | Jiangmen Dacheng Medical Equipment Co., Ltd. | 68 |
| IOB | Iob Medical, Inc. | 61 |
| 3M™ Bair Hugger™ | 3M Company | 61 |
| Cocoon | Care Essentials PTY Ltd | 59 |
| Soft Air | Adroit Medical Systems, Inc. | 56 |
| Level 1 | ICU Medical, Inc | 49 |
| System, Thermal Regulating | Hangzhou Tappa Medical Technology Co., Ltd. | 47 |
| PremierPro | Prestige Ameritech | 39 |
| Bair Paws™ | 3M Company | 30 |
| SourceMark | Sourcemark, LLC. | 25 |
Showing 12 of 166. All products under System, Thermal Regulating
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251974 | 2025-10-24 |
| K243942 | 2025-04-30 |
| K200225 | 2020-02-28 |
| K161602 | 2016-09-02 |
| K142702 | 2014-12-18 |
| K120849 | 2012-07-20 |
| K101092 | 2010-07-16 |
| K071341 | 2007-08-03 |
| K010338 | 2001-03-07 |
| K002577 | 2000-10-26 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-06-27 | Class II | Software design | If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction | 10507 | |
| 2024-02-16 | Class II | Process control | Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system. | 1,654 | |
| 2005-01-05 | Not classified | Other | Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature. | 67 units | 2005-03-25 |
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.