Product code MPO
- Device name
- Infant Heel Warmer (Chemical Heat Pack)
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5710
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler® | International Biomedical | 2022-10-07 |
| K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | CooperSurgical, Inc. | 2016-03-18 |
| K150627 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid Corp. | 2015-05-27 |
| K103549 | DENOVO TEDDY GEL INFANT HEEL WARMER | Denovo Products, LLC | 2011-04-08 |
| K053254 | INFANT HEEL WARMER BY INTCO | Shanghai Intco Medical Supply Co., Ltd. | 2006-09-19 |
| K040856 | RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER | Rapid Aid , Ltd. | 2004-05-03 |
| K040044 | HEEL SNUGGLER, MODEL 99047 | Respironics, Inc. | 2004-01-27 |
| K032989 | MEDI-HEAT INFANT HEEL WARMER | Mediheat, Inc. | 2003-10-22 |
| K964523 | RECOVER INFANT HEEL WARMER (5100) | Florida Medical Industries, Inc. | 1997-02-10 |
| K961154 | BAXTER SODIUM ACETATE INFANT HEEL WARMER | Baxter Healthcare Corp | 1996-06-06 |
| K954716 | DEROYAL INDUSTRIES INFANT HEEL WARMER | Debusk Knitting Mills, Div. Deroyal Industries | 1996-01-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885914108048 | Sammons Preston | Performance Health Supply, LLC | 2026-01-23 |
| 40080196749967 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-10-21 |
| 00080196749969 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-10-21 |
| 20860011917490 | MEDZAH INFANT HEEL WARMER | Medzah Industries | 2025-07-30 |
| 10860011917493 | MEDZAH INFANT HEEL WARMER | Medzah Industries | 2025-07-30 |
| 00850061859228 | GCB Medical Supply | GCB MEDICAL LLC | 2025-07-29 |
| 10080196719655 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-07-01 |
| 10885632413834 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | 2024-03-04 |
| 10885632413803 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | 2024-03-01 |
| 10888277400290 | Medline | MEDLINE INDUSTRIES, INC. | 2023-10-13 |
| 10885380193217 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-06-19 |
| 10192253061468 | NOVAPLUS | Cardinal Health 200, LLC | 2023-02-27 |
| 10192253061420 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-02-21 |
| 10192253061437 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-02-21 |
| 20888937025693 | Cooper Surgical INFANT HEEL WARMER | Coopersurgical, Inc. | 2022-11-29 |
| 10850046230094 | Future Generation Medical | Global International L. L. C. | 2022-11-13 |
| 10850046230100 | Future Generation Medical | Global International L. L. C. | 2022-11-13 |
| 20885632366267 | MediChoice | OWENS & MINOR DISTRIBUTION, INC. | 2022-05-13 |
| 00749756312929 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-07-09 |
| 00080196734941 | Medline | MEDLINE INDUSTRIES, INC. | 2021-05-14 |
| 10885632057755 | MediChoice | OWENS & MINOR DISTRIBUTION, INC. | 2020-09-30 |
| 00818566017611 | PremierPro | PRESTIGE AMERITECH, LTD. | 2020-08-04 |
| 10612479153421 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-20 |
| 10612479191195 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-03-31 |
| 00849027001801 | HCS | DYAD MEDICAL SOURCING, LLC | 2019-12-31 |
| 20885380073851 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-05-30 |
| 10630140017391 | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC | 2018-12-28 |
| 20630140017398 | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC | 2018-12-28 |
| 30884527004625 | Argyle | Cardinal Health, Inc. | 2018-06-30 |
| 30884527004632 | Argyle | Cardinal Health, Inc. | 2018-06-30 |