| Primary Device ID | 05712714604010 |
| NIH Device Record Key | f0bd1999-a8f2-4f62-a7ea-792f8d5f23ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EmbryoScope+ |
| Version Model Number | ES-P1 |
| Catalog Number | 16401 |
| 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 | +4570230500 |
| support.embryoscope@vitrolife. |
| Weight | 50 Kilogram |
| Height | 50 Centimeter |
| Depth | 60 Centimeter |
| Width | 55 Centimeter |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *< 2000 m above sea level (during operation) |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05712714604010 [Primary] |
| MQK | Labware, Assisted Reproduction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-05-24 |
| 05712714000041 - EmbryoSlide+ ic8 dish | 2022-08-29 The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo culture, handling and preparation for |
| 05712714675317 - KIDScore D3 | 2019-12-06 The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by sco |
| 05712714604010 - EmbryoScope+ | 2018-07-06EmbryoScope+ consists of the following devices with the following indications for use: The EmbryoScope+ incubator provides an environment with control |
| 05712714604010 - EmbryoScope+ | 2018-07-06 EmbryoScope+ consists of the following devices with the following indications for use: The EmbryoScope+ incubator provides an en |
| 05712714663505 - EmbryoSlide culture dish | 2018-07-06 The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only |
| 05712714664502 - EmbryoSlide+ culture dish | 2018-07-06 The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reserv |
| 05712714666049 - Micro well group culture dish, 9-well | 2018-07-06 The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The nine (9) microwells are intended fo |
| 05712714666063 - Micro well group culture dish, 16-well | 2018-07-06 The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The sixteen (16) microwells are intende |
| 05712714603013 - EmbryoScope time-lapse incubator | 2018-03-29 The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for |