FDA.reportPublic FDA data

EmbryoScope time-lapse incubator

Primary DI
05712714603013
Brand
EmbryoScope time-lapse incubator
Company
Vitrolife A/S
Model
ESD20000
Catalog number
ESD20000
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.
Published
2016-08-26
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
MQGAccessory, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQGAccessory, Assisted ReproductionObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712714603013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712714603013057127146030135712714603013

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction incubator/microscope camera systemAn 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].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature20 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Keep dry
Storage Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+46317218020support.fertility@vitrolife.co
+46317218020support.fertility@vitrolife.com
+4572217900order@vitrolife.com
+4570230500support.embryoscope@vitrolife.com

Regulatory Flags#

DUNS number
308547608
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05712714676123ES server7166122026-04-16
05712714676222EmbryoViewer7166222026-04-16
05712714000041EmbryoSlide+ ic8 dish16455164552022-08-20
05712714675317KIDScore D316531165312019-11-28
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

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Primary DI, Brand, Company table
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00888937032833LifeGlobal® Coda®Coopersurgical, Inc.MQG2026-08-03
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00888937032871LifeGlobal® Coda®Coopersurgical, Inc.MQG2026-08-03
00888937032901LifeGlobal® Coda®Coopersurgical, Inc.MQG2026-08-03
00888937032918LifeGlobal® Coda®Coopersurgical, Inc.MQG2026-08-03
00888937033915ORIGIOl®Coopersurgical, Inc.MQG2026-08-03
05712714676123ES serverVitrolife A/SMQG2026-04-16
05712714676222EmbryoViewerVitrolife A/SMQG2026-04-16
04779041940144Dish for MIRI TLESCO MEDICAL TECHNOLOGIES UABMQG2026-01-15
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04779041940229Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABMQG2026-01-15
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