| 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 |
| 06941691934233 - Orantech | 2026-02-06 Philips Compatible, 3-Lead, AHA, 2.5M |
| 06941691934240 - Orantech | 2026-02-06 Philips Compatible, 3-Lead, IEC, 2.5M |
| 06941691938279 - Orantech | 2026-02-06 Philips Compatible, 3-Lead, Grabber End, AHA, 0.9m |
| 06941691948865 - Orantech | 2026-02-06 Philips Compatible, 3-Lead, Grabber End, IEC, 0.9m |
| 06941691983132 - Orantech | 2026-02-06 Kopran Compatible, use with MD6M Pressure Transducer, 0.17m |
| 06941691905431 - Orantech | 2026-01-26 Philips Compatible, use with Mindray Pressure Transducer, 4.0m |
| 06941691982906 - Orantech | 2026-01-26 GE Compatible, use with MD6M Pressure Transducer, 0.17m |
| 06941691982913 - Orantech | 2026-01-26 Spacelabs Compatible, use with MD6M Pressure Transducer, 0.17m |