EmbryoScope+
Basic Information
- Brand Name
- EmbryoScope+
- Primary DI
- 05712714604010
- Version / Model
- ES-P1
- Catalog Number
- 16401
- Company Name
- Vitrolife A/S
- Labeler DUNS
- 308547608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-24
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- f0bd1999-a8f2-4f62-a7ea-792f8d5f23ac
Device Description
EmbryoScope+ consists of the following devices with the following indications for use: The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development. The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator. The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not control any hardware components in the EmbryoScope+ incubator. The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters. The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQK | Labware, Assisted Reproduction | Obstetrics/Gynecology | 884.6160 | 2 |
| MTX | Microscope And Microscope Accessories, Reproduction, Assisted | Obstetrics/Gynecology | 884.6190 | 1 |
| MQG | Accessory, Assisted Reproduction | Obstetrics/Gynecology | 884.6120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61195 | Assisted reproduction incubator/microscope camera system | An assembly of mains electricity (AC-powered) devices intended to be used during assisted reproduction/in vitro fertilization (IVF) to incubate reproductive biological materials (e.g., gametes and embryos) at closely regulated and monitored temperatures, whilst acquiring, processing, and storing images of the embryo cultures, over the course of development, to assist embryo selection. It consists of an incubator with a built-in digital microscope still camera, monitor, and software; it may include additional supportive devices (e.g., printer). The system may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentrations]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05712714604010 | GS1 |
Customer Contacts
- Phone
- +4570230500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173264 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 50 | Kilogram | |
| Height | 50 | Centimeter | |
| Depth | 60 | Centimeter | |
| Width | 55 | Centimeter |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 80 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- < 2000 m above sea level (during operation)
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 28 Degrees Celsius