Warmgel Instant Heat Pack – Medium
Catalogue number 20419, listed by Coopersurgical, Inc., United States, under Pack, Hot Or Cold, Disposable. 176 manufacturers in China are registered for this product code.
176manufacturers in China registered for this device type
1catalogue number
6recalls on this code
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 | Coopersurgical, Inc., 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 |
| 510(k) | K912715 |
| Record published | 2022-11-29 |
| Record revised | 2024-02-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20419 | 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
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | 510(k) number | 2015-01-26 | Class II | Package design/selection | Products without expiration date have the remote potential for minor burn | 20398889 units | 2016-06-14 |
| Coopersurgical, Inc. | 510(k) number | 2015-01-26 | Class II | Package design/selection | Products without expiration date have the remote potential for minor burn | 8865584 units | 2016-06-14 |
| Coopersurgical, Inc. | 510(k) number | 2015-01-26 | Class II | Package design/selection | Products without expiration date have the remote potential for minor burn | 18696754 units | 2016-06-14 |
| Coopersurgical, Inc. | 510(k) number | 2015-01-26 | Class II | Package design/selection | Products without expiration date have the remote potential for minor burn | 4938266 units | 2016-06-14 |
Recalls
2 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 | Closed |
|---|---|---|---|---|---|
| 2019-07-08 | Class II | Error in labeling | The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products d | 49813 | 2020-05-28 |
| 2013-05-01 | Class II | Package design/selection | Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification | 4,807,566 | 2016-06-14 |
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.