| Primary Device ID | 00843997011648 | 
| NIH Device Record Key | 63594d31-0e5d-4f38-aea0-3d588c9bde79 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | rainbow SET | 
| Version Model Number | 4100 | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00843997011648 [Primary] | 
| BZQ | Monitor, breathing frequency | 
| 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 | 
| 10843997012741 | rainbow SET module | 
| 10843997012604 | rainbow SET module | 
| 00843997011648 | 4100 | 
| 00843997013918 | rainbow SET Module | 
| 00843997010818 | rainbow SET CARESCAPE SpO2 - Masimo Pulse CO-Oximetry | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() RAINBOW SET  86668636  5874515 Live/Registered  | 
        Masimo Corporation  2015-06-19  |