AccessGUDID - DEVICE: EmbryoScope+ (05712714604010)

GUDID

Device Identifier (DI) Information

Brand Name: EmbryoScope+
Version or Model: ES-P1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16401
Company Name: Vitrolife A/S

Primary DI Number: 05712714604010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308547608 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQK	Labware, Assisted Reproduction
MTX	Microscope And Microscope Accessories, Reproduction, Assisted
MQG	Accessory, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173264	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: < 2000 m above sea level (during operation)
Handling Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 20 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 50 Kilogram
Height: 50 Centimeter
Depth: 60 Centimeter
Width: 55 Centimeter

Device Record Status

Public Device Record Key: f0bd1999-a8f2-4f62-a7ea-792f8d5f23ac
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: May 24, 2018