| Primary Device ID | 04987486015147 |
| NIH Device Record Key | a2b1d9a2-8625-4038-9ad9-c0ebd5b19c36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Calibrator 80 |
| Version Model Number | 103400 |
| Company DUNS | 008171162 |
| Company Name | ARKRAY USA, INC. |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1-855-646-3108 |
| xxx@xxx.xxx |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987486015147 [Primary] |
| JIT | Calibrator, Secondary |
| 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 | 2017-12-08 |
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