| Primary Device ID | 00860396000615 |
| NIH Device Record Key | 7aa217aa-d264-4af6-b345-16a67c24998d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oh’Care Lite Blood Glucose Test strips |
| Version Model Number | IGM-1003A |
| Catalog Number | INFS003L |
| Company DUNS | 081064046 |
| Company Name | IJDREAM CORPORATION |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 800-925-2949 |
| support@ijdream.com |
| Total Volume | 0.5 Microliter |
| Storage Environment Temperature | Between 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860396000615 [Primary] |
| LFR | Glucose Dehydrogenase, Glucose |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-05 |
| Device Publish Date | 2018-06-30 |
| 00860313000933 - Oh'Care Lite | 2023-04-10 Glucose Control Solution Level 2 |
| 00850002937428 - ijCare | 2020-03-09 |
| 00860313000919 - Oh’Care Lite Blood Glucose Monitoring System for Self-Testing | 2019-12-05 Blood Glucose Monitoring System for Self-Testing |
| 00860396000615 - Oh’Care Lite Blood Glucose Test strips | 2019-12-05Blood Glucose Test strips |
| 00860396000615 - Oh’Care Lite Blood Glucose Test strips | 2019-12-05 Blood Glucose Test strips |
| 00860396000608 - ijCare | 2019-05-31 |