| Primary Device ID | 00850048825000 |
| NIH Device Record Key | 2f59f236-3e83-4d9a-9cc4-ae40e912f347 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bronchoscope |
| Version Model Number | 10000769 |
| Company DUNS | 117566482 |
| Company Name | Noah Medical Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850048825000 [Primary] |
| EOQ | Bronchoscope (Flexible Or Rigid) |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850048825000]
Ethylene Oxide
[00850048825000]
Ethylene Oxide
[00850048825000]
Ethylene Oxide
[00850048825000]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-19 |
| Device Publish Date | 2024-12-11 |
| 00850048825055 - Accessory Kit | 2024-12-23 Galaxy system accessory kit |
| 00850048825062 - Basic Accessory Kit | 2024-12-23 Galaxy system basic accessory kit |
| 00850048825000 - Bronchoscope | 2024-12-19The Galaxy System and bronchoscopic is intended to provide visualization of patient airways for diagnostic procedures. |
| 00850048825000 - Bronchoscope | 2024-12-19 The Galaxy System and bronchoscopic is intended to provide visualization of patient airways for diagnostic procedures. |
| 00850048825017 - Bronchoscope connector | 2024-12-19 Bronchoscope connector |
| 00850048825031 - Bronchoscope guide | 2024-12-19 Scope guide |
| 00000850048825 - Galaxy System | 2024-11-19 The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable br |