PremierPro
Warming Blanket, Pre Warming Gown, Size Medium plus Kit 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or…
Warming Blanket, Pre Warming Gown, Size Medium plus Kit 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer → Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer – Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
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 | Prestige Ameritech, United States |
|---|---|
| FDA product code | DWJ |
| Device type | System, Thermal Regulating |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5900 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-04-05 |
| Record revised | 2026-03-23 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date |
| Packaging | Case of 10, case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3851 | In distribution | |
| 3831 | In distribution | |
| 3845 | In distribution | |
| 3835 | In distribution | |
| 3877 | In distribution | |
| 3858 | In distribution | |
| 3842 | In distribution | |
| 3856 | In distribution | |
| 3853 | In distribution | |
| 3824 | In distribution | |
| 3834 | In distribution | |
| 3822 | In distribution | |
| 3867 | In distribution | |
| 3866 | In distribution | |
| 3860 | In distribution | |
| 3828 | In distribution | |
| 3863 | In distribution | |
| 3875 | In distribution | |
| 3861 | In distribution | |
| 3857 | In distribution | |
| 3846 | In distribution | |
| 3843 | In distribution | |
| 3868 | In distribution | |
| 3854 | In distribution | |
| 3855 | In distribution | |
| 3832 | In distribution | |
| 3862 | In distribution | |
| 3869 | In distribution | |
| 3847 | In distribution | |
| 3841 | In distribution | |
| 3823 | In distribution | |
| 3826 | In distribution | |
| 3829 | In distribution | |
| 3844 | In distribution | |
| 3852 | In distribution | |
| 3879 | In distribution | |
| 3833 | In distribution | |
| 3859 | In distribution | |
| 3827 | 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 |
| Bair Paws™ | 3M Company | 30 |
| SourceMark | Sourcemark, LLC. | 25 |
| Kozee | Sourcemark, LLC. | 24 |
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.