| Primary Device ID | 00884838111400 |
| NIH Device Record Key | 2483769f-957b-474e-8a5a-d3a4828b6b68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MR Patient Care Temperature Sensor Jacket |
| Version Model Number | Temperature Sensor Jacket |
| Catalog Number | 989803178181 |
| Company DUNS | 314101143 |
| Company Name | Philips Medizin Systeme Böblingen GmbH |
| Device Count | 10 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| 00884838111370 - MR Patient Care SpO2 Sensor | 2025-06-09 Fiber Optic SpO2 Sensor for use with Wireless SpO2 3.0 Module (Networks 1-5) 989803192771 and SpO2 Clips and Grips accessories |
| 00884838111479 - MR Patient Care Temperature Sensor (Esophageal / Rectal / Axillary, Direct Mode) | 2025-06-09 Temperature sensor for Expression MRI patient monitors, capable of surface measurement or, with applied FlexTEMP Jacket, esophog |
| 00884838111400 - MR Patient Care Temperature Sensor Jacket | 2025-06-09Disposable Flex Temp Jacket is designed for use with the FlexTEMP System, Sensor. The FlexTEMP Jacket must be used with the FlexTEMP Sensor while measuring Body temperature. This Sensor should also be used for surface temperature to reduce the occurrence of infection |
| 00884838111400 - MR Patient Care Temperature Sensor Jacket | 2025-06-09 Disposable Flex Temp Jacket is designed for use with the FlexTEMP System, Sensor. The FlexTEMP Jacket must be used with the Flex |
| 00884838120563 - MR Patient Care Kit, Sample, Agents, 3160 | 2025-05-29 KIT,SAMPLE,AGENTS,3160 |
| 00884838117839 - MR Patient Care Single Patch ECG Electrodes (25) | 2025-05-29 QUADTRODE MRI ECG PAD,25/BOX |
| 00884838117846 - MR Patient Care Multiple Patch ECG Electrodes (25) | 2025-05-29 ELECTRODE, MRI ECG, QUADTRODE CV, 25/BOX |
| 00884838117853 - MR Patient Care Neonatal ECG Electrodes (25) | 2025-05-29 ELECTRODE, NEONATE MRI ECG, QUADTRODE CV, 25/BOX |
| 00884838120532 - MR Patient Care Short Wide ECG 2.0 Cable AAMI | 2025-05-28 CAB,4 LD,CV MRI ECG,3160 |