| Primary Device ID | 00840682116800 |
| NIH Device Record Key | 20bc5b31-c8cc-4e56-a90b-5aa4eb077b50 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 2069156-001 |
| Company DUNS | 401966697 |
| Company Name | GE Healthcare Finland Oy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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(800)558-5120 |
| xx@xx.xx |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682116800 [Primary] |
| ORT | Burst suppression detection software for electroencephalograph |
| 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 | 2016-06-30 |
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