AccessGUDID - DEVICE: KIDScore D3 (05712714675317)

GUDID

Device Identifier (DI) Information

Brand Name: KIDScore D3
Version or Model: 16531
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16531
Company Name: Vitrolife A/S

Primary DI Number: 05712714675317
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308547608 *Terms of Use

Device Description: 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.

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?
61196	Assisted reproduction embryo-assessment software	An application software program intended to analyse image data captured by an embryo-assessment microscope camera system to store, and allow comparison/evaluation of, acquired embryo images, to assist embryo selection during assisted reproduction/in vitro fertilization (IVF). Typically it allows the user to store relevant patient medical records, analyse still images and videos of embryonic growth, annotate or categorize images, and may provide decision support. It is intended to be used by healthcare professionals in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBH	Embryo Image Assessment System, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182798	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7ae9164c-1b1b-4126-b22c-49c4b7510690
Public Version Date: December 06, 2019
Public Version Number: 1
DI Record Publish Date: November 28, 2019