| Primary Device ID | 04779041940816 |
| NIH Device Record Key | 64d44fe5-4a9b-43aa-9736-42b218a787dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Multiroom IVF incubator |
| Version Model Number | MIRI M Docking Station |
| Company DUNS | 365831125 |
| Company Name | ESCO MEDICAL TECHNOLOGIES UAB |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04779041940816 [Primary] |
| PUB | Accessory, Assisted Reproduction, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-23 |
| Device Publish Date | 2026-01-15 |
| 04779041940243 | The Esco Medical MIRI® family’s multiroom IVF incubators are intended to be used to provide a |
| 04779041940816 | The Esco Medical MIRI® M multiroom IVF incubators are intended to be used by trained healthcare |
| 04779041940809 | The Esco Medical MIRI® M multiroom IVF incubators are intended to be used by trained healthcare |
| 04779041940267 | The Esco Medical MIRI® family’s multiroom IVF incubators are intended to be used to provide a |