| Primary Device ID | 00860010859728 |
| NIH Device Record Key | 537dde66-8dca-4feb-89af-0f9f7ce01992 |
| Commercial Distribution Discontinuation | 2030-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneScope Pro |
| Version Model Number | Pro - Pediatric Size 2 Blade |
| Company DUNS | 116913619 |
| Company Name | One-AI Healthcare, Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00860010859728 [Primary] |
| CCW | Laryngoscope, Rigid |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
[00860010859728]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-11 |
| Device Publish Date | 2023-10-03 |
| 00860010859766 | Pro - Direct Adult Mac 4 Blade |
| 00860010859759 | Pro - Angulated Adult Size 4 Blade |
| 00860010859742 | Pro - Direct Adult Mac 3 Blade |
| 00860010859735 | Pro - Angulated Adult Size 3 Blade |
| 00860010859728 | Pro - Pediatric Size 2 Blade |
| 00860010859711 | Pro - Neonatal Size 1 Blade |
| 00860010859704 | OneScope Pro Video Laryngoscope |