Hypothermia Management Set
HYPOTHERMIA MANAGEMENT SET 1 ea - 7.5" x 6.5" Blizzard Light Blanket, 1 ea - 34" x 48" Ready-Heat warming blanket WARNING: Do not place Ready-Heat on exposed skin.
Who Else Makes It
Concentrated in Zhejiang (39), Jiangsu (38), Guangdong (21). 22 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
| Wuhan Huawei Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 16 |
| Zhejiang Changdi Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 16 |
| Jiangsu Classic NEW-Type Medical Products Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Hanghai Medical Products Co Ltd | Jinhua | Zhejiang | Contract manufacturer | 10 |
Showing 12 of 176. All 176 manufacturers in China registered for Pack, Hot Or Cold, Disposable
Record
| Listed by | Safeguard US Operating, LLC, United States |
|---|---|
| FDA product code | IMD |
| Device type | Pack, Hot Or Cold, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5710 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-04 |
| Record revised | 2025-01-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Distribution end date | 2025-01-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ANF Therapy® | Amino Frequency Corporation SL. | 47 |
| Cardinal Health | Cardinal Health 200, LLC | 44 |
| Medline | Medline Industries, Inc. | 24 |
| ThermaCare HeatWraps | Pfizer Inc | 19 |
| Halyard | Owens & Minor Distribution, Inc. | 15 |
| DeRoyal | Deroyal Industries, Inc. | 14 |
| Halyard | O&M Halyard, Inc. | 14 |
| McKesson | Mckesson Medical-Surgical Inc. | 13 |
| HCS | Dyad Medical Sourcing, LLC | 13 |
| Novaplus | Cardinal Health 200, LLC | 13 |
| Curaplex | Bound Tree Medical, LLC | 13 |
| MediChoice | Owens & Minor Distribution, Inc. | 11 |
Showing 12 of 150. All products under Pack, Hot Or Cold, Disposable
Recalls
3 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 |
|---|---|---|---|---|
| 2024-08-27 | Class II | Process control | Incorrect expiration date. | 567 units |
| 2024-08-27 | Class II | Process control | Incorrect expiration date. | 655 units |
| 2024-08-27 | Class II | Process control | Incorrect expiration date. | 408 units |
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.