Infa-Therm Mattress
The Infa-Therm infant warming mattress is an instant warm pack for transporting an infant within a hospital or between hospitals. It is recommended for full-term infants and provides warmth…
The Infa-Therm infant warming mattress is an instant warm pack for transporting an infant within a hospital or between hospitals. It is recommended for full-term infants and provides warmth from a disposable mattress placed beneath the infant.
Flexing a catalyst disc inside the pouch starts crystallization of a supersaturated sodium acetate and water solution. This reaction releases heat without an external power supply. The mattress warms after activation, then gradually cools over time.
Listed Item
Infa-Therm Infant Warming Mattress
Construction and Supply
The rectangular pouch measures approximately 10 by 16 inches. It uses polyethylene material with a polyester layer on its underside and is supplied nonsterile for a single use.
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 | International Biomedical, Ltd., United States |
|---|---|
| FDA product code | IMD |
| Device type | Pack, Hot Or Cold, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5710 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K221653 |
| Record published | 2023-04-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1015 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221653 | 2022-10-06 |
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.