Cardinal Health
Pack HOT/Cold 4.5IN X 10.5IN Soft Freeze Pack Heated IN Microwave FOR Warm Therapy Medium Reusable
178manufacturers in China registered for this device type
10catalogue numbers in this listing
8recalls on this code
Who Else Makes It
Concentrated in Guangdong (52), Jiangsu (45), Zhejiang (30). 26 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Picard Healthcare Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Dongguan NAN YOU Sporting Goods Enterprise Ltd | Dongguan | Guangdong | Contract manufacturer | 23 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Zhejiang Changdi Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 16 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
Showing 12 of 178. All 178 manufacturers in China registered for Pack, Hot Or Cold, Reusable
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | IME |
| Device type | Pack, Hot Or Cold, Reusable |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5700 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-06 |
| Record revised | 2026-01-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 24, case of 6, case of 12 |
| Sizes | Height 5.1 in; width 10.5 in |
| Distribution end date | 2018-06-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 70204 | In distribution | ||
| 80600 | In distribution | ||
| 70304A | In distribution | ||
| 80304A | Height 5.1 in | In distribution | |
| 80104 | 24 | In distribution | |
| 80204A | In distribution | ||
| 11429-015 | 400 | In distribution | |
| 70304 | In distribution | ||
| 61115 | 150 | In distribution | |
| 70304R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bingfan | Shanghai BingFan Industrial Co., Ltd. | 69 |
| Arctic Flex | Vive Health LLC | 62 |
| DeRoyal | Deroyal Industries, Inc. | 39 |
| Zhanzun | Anhui Zhanzun Industrial Co., Ltd. | 34 |
| Vive | Vive Health LLC | 25 |
| Sharper Image | Merchsource LLC | 25 |
| Cryopush | Chengdu Cryo-Push Medical Technology Co., Ltd. | 23 |
| Freeze Sleeve | Jiangsu Huanyi Industrial Co., Ltd. | 22 |
| Polar Ice | Brownmed | 18 |
| Squid | Portable Therapeutix | 15 |
| Squid Go | Portable Therapeutix | 14 |
| Squid Rx | Portable Therapeutix | 12 |
Showing 12 of 191. All products under Pack, Hot Or Cold, Reusable
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 2022-09-28 | Class II | Pending | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates. | 129412 units |
Recalls
7 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 |
|---|---|---|---|---|
| 2022-09-28 | Class II | Pending | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates. | 499997 units |
| 2022-09-28 | Class II | Pending | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates. | 409738 units |
| 2022-09-28 | Class II | Pending | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates. | 414194 units |
| 2022-09-28 | Class II | Pending | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates. | 649213 units |
| 2022-09-28 | Class II | Pending | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates. | 1915308 units |
| 2022-09-28 | Class II | Pending | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates. | 1209260 units |
| 2022-09-28 | Class II | Pending | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates. | 567475 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.