| Primary Device ID | 10843997000731 |
| NIH Device Record Key | 35e801c8-703f-4f3d-b18b-35d6a55e6825 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MasimoSET® Replacement Tapes |
| Version Model Number | 2308 |
| Company DUNS | 780421038 |
| Company Name | MASIMO CORPORATION |
| Device Count | 102 |
| 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 | 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843997000734 [Unit of Use] |
| GS1 | 10843997000731 [Primary] |
| DQA | Oximeter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-08-23 |
| 10843997004081 | 2822 |
| 10843997000731 | 2308 |