| Primary Device ID | 05712714603013 |
| NIH Device Record Key | c55e751c-e75e-4951-85c7-51e54c04bebc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EmbryoScope time-lapse incubator |
| Version Model Number | ESD20000 |
| Catalog Number | ESD20000 |
| Company DUNS | 308547608 |
| Company Name | Vitrolife A/S |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | +46317218020 |
| support.fertility@vitrolife.co |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05712714603013 [Primary] |
| MQG | Accessory, Assisted Reproduction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-26 |
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