| Primary Device ID | 00855913001817 |
| NIH Device Record Key | 5e4a00c0-ac06-4aeb-94b9-358aadc8b173 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32") |
| Version Model Number | U501 |
| Catalog Number | U501 |
| Company DUNS | 965879187 |
| Company Name | AUGUSTINE TEMPERATURE MANAGEMENT LLC |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00855913001817 - HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32") | 2023-07-25The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients.
Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings.
Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery. |
| 00855913001817 - HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32") | 2023-07-25 The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controllin |
| 00855913001824 - HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50") | 2023-07-25 The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controllin |
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