| Primary Device ID | 03661540301490 |
| NIH Device Record Key | d51d46f3-6c71-49a3-94f1-8ec8cd4edac1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTIMOLE™ Osmolality Standard, 290 mmol/kg, 60x.4mL |
| Version Model Number | OA-290 |
| Company DUNS | 052423787 |
| Company Name | ELITECHGROUP INC. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | false |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
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