| Primary Device ID | 00793150629770 |
| NIH Device Record Key | 1d2dafd6-c082-44eb-bec6-976c146a5c25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oh’Care Lite Blood Glucose Monitoring System for Self-Testing |
| Version Model Number | IGM-1003A |
| Catalog Number | INFM003L |
| Company DUNS | 688195374 |
| Company Name | OSANG HEALTHCARE Co., Ltd. |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | true |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Total Volume | 0.5 Microliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00793150629770 [Primary] |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-11-03 |
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