| Primary Device ID | 00850015699153 |
| NIH Device Record Key | 7198e14d-4df0-4bc2-a49e-48e384ee39e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Home Base Station (Bluetooth) |
| Version Model Number | 43-5570-001-15 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00850015699153 [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 | 2024-09-16 |
| Device Publish Date | 2024-09-06 |
| 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) | 2024-09-16The Canary Home Base Station (Bluetooth) subsystem is a unit with embedded firmware that facilitate communication with CTE and CSE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient. |
| 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 |