WarmTouch
Patient Warming System, Patient Warming Unit Hose Assembly (5200/5800)
8manufacturers in China registered for this device type
17catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | DWJ |
| Device type | System, Thermal Regulating |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5900 |
| 510(k) | K123083 |
| Record published | 2017-09-13 |
| Record revised | 2025-06-24 (version 12) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature 18 to 28 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 12 to 95 KiloPascal; Storage environment temperature -40 to 70 °C; Handling environment humidity 15 to 85 % RH; Storage environment humidity 10 to 95 % RH |
| Packaging | Case of 12, case of 25 |
| Distribution end date | 2019-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5016000-RFB | In distribution | |
| 5030900 | In distribution | |
| 5030810 | In distribution | |
| 5030850 | In distribution | |
| 5016000-RC | In distribution | |
| 502-2200 | In distribution | |
| 5030890 | In distribution | |
| 5030840 | In distribution | |
| 5016000 | In distribution | |
| DL5016000 | In distribution | |
| 5030880 | In distribution | |
| 5030870 | In distribution | |
| 5016000-RC | In distribution | |
| 502-2400 | In distribution | |
| 5030860 | In distribution | |
| 502-2000 | Withdrawn | |
| 502-2100 | Withdrawn |
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
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.