| Primary Device ID | 00860003118313 |
| NIH Device Record Key | d658b7a1-010a-41d0-872e-e8c2a96e3a18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Canary OR Base Station / OR PC App / OR Registration |
| Version Model Number | 43-5570-002-14 |
| Company DUNS | 117153396 |
| Company Name | Canary Medical USA LLC |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003118313 [Primary] |
| OUG | Medical Device Data System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-30 |
| Device Publish Date | 2021-09-22 |
| 00860003118399 - Canturio® Smart Extension 14mm (D) x 30mm (H) | 2024-09-20 Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial ext |
| 00850015699153 - Home Base Station (Bluetooth) | 2024-09-16 The Canary Home Base Station (Bluetooth) subsystem is a unit with embedded firmware that facilitate communication with CTE and C |
| 00850015699115 - CanarE Strap | 2023-05-25 |
| 00850015699122 - Canary Clinic Cart | 2023-05-25 |
| 00850015699139 - CanarE Charging Cradle | 2023-05-25 |
| 00860003118344 - CanarE – Clinic Wearable Device | 2023-05-25 |
| 00860003118368 - Canary Clinic Base Station | 2023-05-25 |
| 00860003118382 - Clinic Laptop | 2023-05-25 |