Multiroom IVF incubator

Basic Information

• Brand Name: Multiroom IVF incubator
• Primary DI: 04779041940816
• Version / Model: MIRI M Docking Station
• Company Name: ESCO MEDICAL TECHNOLOGIES UAB
• Labeler DUNS: 365831125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-15
• Public Version: 1
• Public Version Date: 2026-01-23
• Public Version Status: New
• Public Device Record Key: 64d44fe5-4a9b-43aa-9736-42b218a787dd

Device Description

The Esco Medical MIRI® M multiroom IVF incubators are intended to be used by trained healthcare professionals in the in vitro fertilisation (IVF) / assisted reproduction technology (ART) facilities to maintain and provide a stable culture environment with controlled temperature and CO2/O2 gas concentration for fertilised oocytes to the blastocyst stage during IVF / ART treatments and optionally to capture time lapse images of these during incubation.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PUB	Accessory, Assisted Reproduction, Exempt	Obstetrics/Gynecology	884.6120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35482	Aerobic laboratory incubator	A mains electricity (AC-powered) device heated by electrical currents passing through a heating block containing simple resistors (usually coils of nickel-chromium wire) for the purpose of growing microorganisms and cells that require oxygen (O2) for growth. Aerobic incubators are typically used for serology and crystallization studies, tissue culture work, paraffin wax embedding and in vitro fertilization (IVF).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04779041940816	GS1