| Primary Device ID | 00850018561594 |
| NIH Device Record Key | a91123b6-aed8-4c1b-9be2-a35da18f8702 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Infant Heel Warmer |
| Version Model Number | 1223 |
| Catalog Number | 1223 |
| Company DUNS | 073179368 |
| Company Name | INTERNATIONAL BIOMEDICAL, LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850018561594 [Primary] |
| MPO | Infant Heel Warmer (Chemical Heat Pack) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-28 |
| Device Publish Date | 2023-06-20 |
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| 00850018561204 - LC Accu-Bar Temperature Trend Indicator | 2023-06-28 Temperature Trend Indicator |
| 00850018561594 - Infant Heel Warmer | 2023-06-28Infant Heel Warmer |
| 00850018561594 - Infant Heel Warmer | 2023-06-28 Infant Heel Warmer |
| 00850018561600 - Infant Heel Snuggler | 2023-06-28 Infant Heel Snuggler |
| 00850018561648 - NeoPod T, Neonatal Transport Humidification System | 2023-06-28 Neonatal Transport Humidification System |
| 00865648000306 - Aviator Transport Incubator | 2023-06-28 Aviator Transport Incubator |
| 00865648000313 - NuBorne Infant Warmer | 2023-06-28 NuBorne Infant Warmer |