| Primary Device ID | B634SW0121900201060 |
| NIH Device Record Key | ebe87c3c-7f8e-4536-a392-645cea0c2ecd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Monarch Software Laptop v2.1.6 |
| Version Model Number | Version 2.1.6 |
| Company DUNS | 015823456 |
| Company Name | AURIS HEALTH, 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 | false |
| Serial Number | false |
| 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 |
|---|---|
| HIBCC | B634SW0121900201060 [Primary] |
| EOQ | Bronchoscope (Flexible Or Rigid) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-13 |
| Device Publish Date | 2020-03-05 |
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| 20810068810831 - Bronchoscope Fluidics Tubing | 2024-05-13 Bronchoscope Fluidics Tubing |
| 20810068810862 - Monarch Bronchoscope | 2024-05-13 |
| 20810068810879 - Bronchoscope Sheath Valve | 2024-05-13 Bronchoscope Sheath Valve |
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| 10810068810773 - Monarch™ Software Cart v2.2.5 | 2024-02-26 Monarch™ Software Cart v2.2.5 |
| 10810068810780 - Monarch™ Laptop P70 Linux USB Image v2.2.5 | 2024-02-26 Monarch™ Laptop P70 Linux USB Image v2.2.5 |
| 10810068810797 - Monarch™ Laptop P17/P73 Linux USB Image v2.2.5 | 2024-02-26 Monarch™ Laptop P17/P73 Linux USB Image v2.2.5 |