| Primary Device ID | 00843997013413 | 
| NIH Device Record Key | ef55092c-ac90-45fd-b55d-61e7af77b025 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | rainbow | 
| Version Model Number | 4484 | 
| Company DUNS | 780421038 | 
| Company Name | MASIMO CORPORATION | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | |
| Phone | +1(949)297-7498 | 
| TechService-US@masimo.com | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius | 
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00843997013413 [Primary] | 
| DQA | Oximeter | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-05-21 | 
| Device Publish Date | 2021-05-13 | 
| 00843997012751 | rainbow SET IntelliVue Module signal extraction pulse co-oximeter | 
| 00843997008983 | rainbow DCI - mini SC 400 reusable sensor | 
| 00843997008976 | rainbow DCI - mini SC 200 reusable sensor | 
| 00843997008853 | rainbow DCI - mini SC 1000 reusable sensor | 
| 00843997013420 | RC25-4RA EMS rainbow Patient Cable 4ft./1.2m. | 
| 00843997013413 | 4484 | 
| 00843997013406 | RC25-4 EMS rainbow Patient Cable 4ft./1.2m. | 
| 00843997013390 | 4482 | 
| 00843997013383 | rainbow RC-4 EMS rainbow Patient Cable 4ft./1.2m. | 
| 00843997013376 | 4480 | 
| 00843997008990 | Rainbow DCI-mini SC 1000, 1/Box, Masimo | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  RAINBOW  98827056  not registered Live/Pending | Tub Works, LLC 2024-10-29 | 
|  RAINBOW  98783805  not registered Live/Pending | HOLLYCORP INC. 2024-10-03 | 
|  RAINBOW  98469166  not registered Live/Pending | The Gar 2024-03-26 | 
|  RAINBOW  98447942  not registered Live/Pending | Ashley Hurst LLC 2024-03-13 | 
|  RAINBOW  98447928  not registered Live/Pending | Ashley Hurst LLC 2024-03-13 | 
|  RAINBOW  98231786  not registered Live/Pending | All American Brands Inc 2023-10-19 | 
|  RAINBOW  97668141  not registered Live/Pending | Tamlann Investments Ltd 2022-11-08 | 
|  RAINBOW  97610232  not registered Live/Pending | Blackmore Richard H. 2022-09-28 | 
|  RAINBOW  97278926  not registered Live/Pending | Rainbow MGA Insurance Agency, Inc. 2022-02-22 | 
|  RAINBOW  97227645  not registered Live/Pending | Muffler Man Supply Co. 2022-01-19 | 
|  RAINBOW  97209400  not registered Live/Pending | Rainbow Asian LLC 2022-01-08 | 
|  RAINBOW  97170467  not registered Live/Pending | Yang, Yuxiang 2021-12-14 |