| Primary Device ID | 10843997000717 |
| NIH Device Record Key | 8251bcd8-ff70-41e4-a425-0b47329dabba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MasimoSET® SofTouch™ Replacement Wraps |
| Version Model Number | 2309 |
| Company DUNS | 780421038 |
| Company Name | MASIMO CORPORATION |
| Device Count | 10 |
| 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 | 00843997000710 [Unit of Use] |
| GS1 | 10843997000717 [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 |
| 10843997002469 | 2322 |
| 10843997000717 | 2309 |