| Primary Device ID | 06941691927785 |
| NIH Device Record Key | 7d8713e5-7947-4a1c-8737-198218c4e65b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable SpO2 Sensors |
| Version Model Number | SSD-001-W09AN |
| Catalog Number | II |
| Company DUNS | 544423370 |
| Company Name | Orantech 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06941691927785 [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 | 2021-01-01 |
| Device Publish Date | 2020-12-24 |
| 06941691918431 - Orantech | 2024-12-25 Pronk Compatible,Use with DC3.5, 1.5M |
| 06941691919025 - Orantech | 2024-12-25 Philips Compatible,Use with MD6M, 1.5M |
| 06941691919094 - Orantech | 2024-12-25 AAMI 6Pins Compatible, use with MD6M Pressure Transducer,1.5m |
| 06941691919841 - Orantech | 2024-12-25 Philips Compatible, use with MD6M Pressure Transducer, 0.17m |
| 06941691920144 - Orantech | 2024-12-25 Mindray Compatible, use with MD6M Pressure Transducer, 0.17m |
| 06941691920250 - Orantech | 2024-12-25 Pronk Compatible, use with MD6M Pressure Transducer,1.8m |
| 06941691920540 - Orantech | 2024-12-25 NIBP Single tube with Connectors |
| 06941691921134 - Orantech | 2024-12-25 Philips Compatible, Infant/Neonate, Single tube, 3.0m |