Warmgel Infant Heel Warmer
The WarmGel Infant Heel Warmer is a disposable warm pack used to increase circulation in an infant’s heel before blood sampling. Flexing a steel disc inside the pouch triggers…
The WarmGel Infant Heel Warmer is a disposable warm pack used to increase circulation in an infant’s heel before blood sampling. Flexing a steel disc inside the pouch triggers crystallization of sodium acetate, releasing heat without an external power source.
The gel contains sodium acetate, water and hydroxyethylcellulose thickener inside a nylon and polyethylene pouch. An attached adhesive strap can hold the pack against the heel.
Use and Handling
Model 20418 is the gel version of the heel warmer. It is supplied nonsterile for single use in hospitals, medical offices and other healthcare facilities. Once activated, its temperature rises and then gradually falls as heat is released.
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Intco Medical Products Co., Ltd. | Zhenjiang New District | Jiangsu | Manufacturer | 18 |
| Danyang Rapid Aid Hot and Cold Therapy Products Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | MPO |
| Device type | Infant Heel Warmer (Chemical Heat Pack) |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5710 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K151845 |
| 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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20418 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Medline | Medline Industries, Inc. | 3 |
| Future Generation Medical | Global International L. L. C. | 2 |
| ASP Medical | ASP Global, LLC | 2 |
| Argyle | Cardinal Health | 2 |
| MediChoice | Owens & Minor Distribution, Inc. | 2 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
| Halyard | Owens & Minor Distribution, Inc. | 2 |
| Novaplus | Cardinal Health 200, LLC | 1 |
| PremierPro | Prestige Ameritech | 1 |
| GCB Medical Supply | GCB Medical LLC | 1 |
| Infant Heel Snuggler | International Biomedical, Ltd. | 1 |
Showing 12 of 20. All products under Infant Heel Warmer (Chemical Heat Pack)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151845 | 2016-03-18 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-07-06 | Class II | No Marketing Application | Product marketed without a 510(k) | 6,344,700 | 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.