KIDScore D3 16531

GUDID 05712714675317

The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability. Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.

Vitrolife A/S

Assisted reproduction embryo-assessment software

Primary Device ID	05712714675317
NIH Device Record Key	7ae9164c-1b1b-4126-b22c-49c4b7510690
Commercial Distribution Status	In Commercial Distribution
Brand Name	KIDScore D3
Version Model Number	16531
Catalog Number	16531
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	false
Manufacturing Date	false
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

Customer Support Contacts

Phone	+1 888-879-9092
Email	support.embryoscope@vitrolife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05712714675317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182798

FDA Product Code

PBH	Embryo Image Assessment System, Assisted Reproduction

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-12-06
Device Publish Date	2019-11-28

Devices Manufactured by Vitrolife A/S

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	2019-12-06The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability. Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.
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+	2018-07-06 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