KIDScore D3

Primary DI
05712714675317
Brand
KIDScore D3
Company
Vitrolife A/S
Model
16531
Catalog number
16531
Device description
The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyststage 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, freezingor continued embryo development when, following morphological assessment on Day 3, there are multiple embryosdeemed suitable for transfer or freezing.The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.
Published
2019-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBHEmbryo Image Assessment System, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBHEmbryo Image Assessment System, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182798000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182798000KIDScore D3Vitrolife A/S2019-07-19PBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712714675317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712714675317057127146753175712714675317

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction embryo-assessment softwareAn 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
308547608
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05712714676123ES server7166122026-04-16
05712714676222EmbryoViewer7166222026-04-16
05712714000041EmbryoSlide+ ic8 dish16455164552022-08-20
05712714603013EmbryoScope time-lapse incubatorESD20000ESD200002016-08-26
05712714604010EmbryoScope+ES-P1164012018-05-24
05712714663505EmbryoSlide culture dishFT-S-ES-DFT-S-ES-D2016-08-26
05712714664502EmbryoSlide+ culture dish16450164502018-05-24
05712714666049Micro well group culture dish, 9-well16604166042017-09-21
05712714666063Micro well group culture dish, 16-well16606166062017-09-21