AccessGUDID - DEVICE: EmbryoScope time-lapse incubator (05712714603013)

GUDID

Device Identifier (DI) Information

Brand Name: EmbryoScope time-lapse incubator
Version or Model: ESD20000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ESD20000
Company Name: Vitrolife A/S

Primary DI Number: 05712714603013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308547608 *Terms of Use

Device Description: The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.

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
MQG	Accessory, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 Temperature: between -10 and 50 Degrees Celsius
Handling Environment Temperature: between 20 and 30 Degrees Celsius
Storage Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Special Storage Condition, Specify: Keep dry
Handling Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c55e751c-e75e-4951-85c7-51e54c04bebc
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 26, 2016