| Primary Device ID | 06900234100054 |
| NIH Device Record Key | a573baac-85c3-43ed-9e28-54b9de4f8f6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Solairs |
| Version Model Number | S200A-300101 |
| Company DUNS | 527945351 |
| Company Name | Solaris Medical Technology, Inc. |
| Device Count | 1 |
| 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 | false |
| Lot Batch | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06900234100054 [Primary] |
| GS1 | 16900234100051 [Package] Package: Box [20 Units] In Commercial Distribution |
| GS1 | 26900234100058 [Package] Package: Box [32 Units] In Commercial Distribution |
| GS1 | 36900234100055 [Package] Package: Box [40 Units] In Commercial Distribution |
| GS1 | 46900234100052 [Package] Package: Box [60 Units] In Commercial Distribution |
| GS1 | 56900234100059 [Package] Package: Box [80 Units] In Commercial Distribution |
| DQA | Oximeter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-09 |
| Device Publish Date | 2017-06-16 |
| 06900234100108 | Nonin Compatible Adult SpO2 Soft-Finger Sensor (3.0m cable) |
| 06900234100054 | BCI Compatible Adult SpO2 Finger Sensor (3.0m cable) |
| 06900234100047 | BCI Compatible Adult SpO2 Finger Sensor (0.9m cable) |
| 06900234100177 | Nonin Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable) |