| Primary Device ID | 00884838111370 |
| NIH Device Record Key | d8393400-34a7-44ea-b0e5-bcb1b5fecb49 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MR Patient Care SpO2 Sensor |
| Version Model Number | SpO2 Sensor |
| Catalog Number | 989803161991 |
| Company DUNS | 314101143 |
| Company Name | Philips Medizin Systeme Böblingen GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 -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 |
| 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 |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838111370 [Primary] |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-09 |
| Device Publish Date | 2025-05-30 |
| 00884838111363 - MR Patient Care Expression Model MR400 MRI Patient Monitoring System | 2025-06-10 Expression Patient Monitor (MR400): 15 inch Widescreen Touchscreen interface, MRI Rating 5,000 gauss 4W/kg SAR 3.0T, 8-Hour Smar |
| 00884838111431 - MR Patient Care Wireless ECG 3.0 Module (Networks 1-5) | 2025-06-10 3rd-Generation wireless ECG module for Expression MRI patient monitors (Networks 1-5). |
| 00884838111448 - MR Patient Care Wireless SpO2 3.0 Module (Networks 1-5) | 2025-06-10 3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 1-5). |
| 00884838111455 - MR Patient Care Wireless SpO2 3.0 Module (Networks 6-10) | 2025-06-10 3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 6-10). |
| 00884838111462 - MR Patient Care Wireless ECG 3.0 Module (Networks 6-10) | 2025-06-10 3rd-Generation wireless ECG module for Expression MRI patient monitors (Networks 6-10). |
| 00884838111370 - MR Patient Care SpO2 Sensor | 2025-06-09Fiber Optic SpO2 Sensor for use with Wireless SpO2 3.0 Module (Networks 1-5) 989803192771 and SpO2 Clips and Grips accessories |
| 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 | 2025-06-09 Disposable Flex Temp Jacket is designed for use with the FlexTEMP System, Sensor. The FlexTEMP Jacket must be used with the Flex |