| Primary Device ID | 03661540301506 |
| NIH Device Record Key | dd3db97d-fab2-4d40-bf2b-562b0a768b6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTIMOLE™ Osmolality Standard, 1000 mmol/kg, 60x.4mL |
| Version Model Number | OA-100 |
| 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 |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540301506 [Primary] |
| JIS | Calibrator, Primary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-01 |
| Device Publish Date | 2021-02-19 |
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