Panels › Physical Medicine › Product code MPO · Class 1
Infant Heel Warmer (Chemical Heat Pack)
Regulation 890.5710
0510(k)s in 12 months (11 all time)
0recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in MPO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 3 |
| CooperSurgical, Inc. | 1 | 1 |
| Covidien LLC | 0 | 2 |
| Rapid Aid , Ltd. | 2 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Debusk Knitting Mills, Div. Deroyal Industries | 1 | 0 |
| Denovo Products, LLC | 1 | 0 |
| Florida Medical Industries, Inc. | 1 | 0 |
| International Biomedical | 1 | 0 |
| Mediheat, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2023 | Cardinal Health 200, LLC NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010 Open, Classified |
MPO | K961154 |
| Jan 19, 2022 | Philips North America Llc Heel Snuggler, Reference # 989805603411 99047 Open, Classified |
MPO | K040044 |
| Jun 9, 2021 | Cardinal Health 200, LLC Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product
SKU MH00002N
The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside t Terminated |
MPO | K964523 |
| Jun 9, 2021 | Cardinal Health 200, LLC Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product
SKU MH00002T
The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the Terminated |
MPO | K964523 |
| Aug 21, 2015 | Covidien LLC Covidien Argyle Infant Heel Warmers (with tab)
Item Code: MH00002T
Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling. Terminated |
MPO | K964523 |
| Aug 21, 2015 | Covidien LLC Covidien Argyle Infant Heel Warmers (no tab)
Item Code: MH00002N
Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling Terminated |
MPO | K964523 |
| Jul 20, 2015 | CooperSurgical, Inc. Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows :
CooperSurgical
PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100;
PN 24401 LIQUI Terminated |
MPO | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.