Infant Heel Warmer
Catalogue number 1223, listed by International Biomedical, Ltd., United States, under Infant Heel Warmer (Chemical Heat Pack). 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | International Biomedical, Ltd., United States |
|---|---|
| FDA product code | MPO |
| Device type | Infant Heel Warmer (Chemical Heat Pack) |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5710 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K221154 |
| Record published | 2023-06-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1223 | 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 |
|---|---|
| K221154 | 2022-10-07 |
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.