| Primary Device ID | 06430033851807 |
| NIH Device Record Key | 89153f33-db40-408f-ba31-452a588c9d4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ST500 Remote |
| Version Model Number | TR01 |
| Company DUNS | 651755092 |
| Company Name | ICARE FINLAND OY |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06430033851807 [Primary] |
| HKX | Tonometer, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-15 |
| Device Publish Date | 2024-11-07 |
| 06430033851784 - ST500 SmartCradle | 2024-11-15 ST500 SmartCradle |
| 06430033851791 - ST500 Adapter | 2024-11-15 ST500 Adapter |
| 06430033851807 - ST500 Remote | 2024-11-15ST500 Remote |
| 06430033851807 - ST500 Remote | 2024-11-15 ST500 Remote |
| 06430033851883 - iCare ST500 | 2024-11-15 iCare ST500 tonometer |
| 06430033851098 - iCare PATIENT2 | 2024-05-01 iCare PATIENT2 (iOS version) |
| 06430033851104 - iCare PATIENT2 | 2024-05-01 iCare PATIENT2 (Android version) |
| 06430033851463 - iCare IC200 | 2023-06-28 iCare IC200 (with Quick Measure feature) |
| 06430033851456 - iCare HOME2 | 2022-02-16 |