Multiroom IVF incubator

GUDID 04779041940212

The Esco Medical MIRI® family’s multiroom IVF incubators are intended to be used to provide a stable culture environment at or near body temperature and CO2/N2 or premixed gases and humidification for the development of gametes and embryos during in vitro fertilization (IVF)/assisted reproduction technology (ART) treatments.

ESCO MEDICAL TECHNOLOGIES UAB

Assisted reproduction heater/incubator
Primary Device ID04779041940212
NIH Device Record Keyec535b63-72c3-4c69-8201-7904c8cff962
Commercial Distribution StatusIn Commercial Distribution
Brand NameMultiroom IVF incubator
Version Model NumberMIRI
Company DUNS365831125
Company NameESCO MEDICAL TECHNOLOGIES UAB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104779041940212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQGAccessory, Assisted Reproduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-23
Device Publish Date2026-01-15

On-Brand Devices [Multiroom IVF incubator]

04779041940229The Esco Medical MIRI® family’s multiroom IVF incubators are intended to be used to provide a
04779041940212The Esco Medical MIRI® family’s multiroom IVF incubators are intended to be used to provide a
04779041940199The Esco Medical MIRI® family’s multiroom IVF incubators are intended to be used to provide a
04779041940168The Esco Medical MIRI® family’s multiroom IVF incubators are intended to be used to provide a

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