| Primary Device ID | 00860008932204 |
| NIH Device Record Key | ddf3eaf7-f0e9-4794-9cf8-50c4cd02ca4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spire Health Remote Patient Monitoring System |
| Version Model Number | 700099 |
| Company DUNS | 081072216 |
| Company Name | CONVEXITY SCIENTIFIC LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 00860008932204 [Primary] |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-07-23 |
| Device Publish Date | 2023-01-03 |
| 00860008932204 - Spire Health Remote Patient Monitoring System | 2025-07-23The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data. |
| 00860008932204 - Spire Health Remote Patient Monitoring System | 2025-07-23 The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically rel |
| 00869112000168 - FLYp | 2021-04-16 Vibrating mesh nebulizer |
| 00869112000175 - FLYp | 2021-04-16 Hypersoniq PDA |
| 00869112000106 - FLYp | 2019-05-15 Vibrating mesh nebulizer |