| Primary Device ID | 20888937801518 |
| NIH Device Record Key | b79b54cf-2686-4c2a-8ba2-a12f11995b82 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EmbryoAssist |
| Version Model Number | 12130060D |
| Company DUNS | 305424269 |
| Company Name | Origio 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 | 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00888937801514 [Primary] |
| GS1 | 20888937801518 [Package] Contains: 00888937801514 Package: 12135060D 5x60 ml [5 Units] In Commercial Distribution |
| MQL | Media, Reproductive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-07-15 |
| 20888937801600 | EmbryoAssist with phenol red. 60 ml |
| 20888937801587 | EmbryoAssist with phenol red. 10 ml |
| 20888937801518 | EmbryoAssist. 60 ml |
| 00888937801491 | EmbryoAssist. 10 ml |