Astopad®
The filing names COV180-NA among the ASTOPAD warming-system models and describes the blanket as an applied part of that system. For COV180-NA, the filing lists a warming blanket measuring…
The filing names COV180-NA among the ASTOPAD warming-system models and describes the blanket as an applied part of that system.
For COV180-NA, the filing lists a warming blanket measuring 1800 by 800 millimeters.
Listed Item
COV180-NA
System Connection
The ASTOPAD system uses a control unit with one or two applied parts. The control unit provides separate outputs and temperature settings for each connected part, with set temperatures from 32 to 39 degrees Celsius in half-degree steps.
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 | Stihler Electronic Gmbh, Germany |
|---|---|
| FDA product code | DWJ |
| Device type | System, Thermal Regulating |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5900 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K202197 |
| Record published | 2020-10-08 |
| Record revised | 2025-11-20 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| COV180-NA | In distribution | |
| COV155-NA | In distribution | |
| COV070-NA | In distribution | |
| COV150-NA | In distribution | |
| COV105-NA | In distribution | |
| DUO310-NA | 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 |
|---|---|
| K260278 | 2026-07-08 |
| K202197 | 2020-09-04 |
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.