Multiroom IVF incubator

GUDID 04779041940243

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 ID: 04779041940243
• NIH Device Record Key: 702cce39-16cf-46c2-b06e-803f3f576b05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multiroom IVF incubator
• Version Model Number: MIRI Humidity
• Company DUNS: 365831125
• Company Name: ESCO MEDICAL TECHNOLOGIES UAB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04779041940243 [Primary]

FDA Product Code

• PUB: Accessory, Assisted Reproduction, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-22
• Device Publish Date: 2026-01-14

Devices Manufactured by ESCO MEDICAL TECHNOLOGIES UAB

• 04779041940243 - Multiroom IVF incubator: 2026-01-22The 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.
• 04779041940243 - Multiroom IVF incubator: 2026-01-22 The Esco Medical MIRI® family’s multiroom IVF incubators are intended to be used to provide a stable culture environment at o
• 04779041940298 - MIRI Time-Lapse Incubator: 2026-01-22 Esco Medical MIRI® TL family`s multiroom IVF incubators are intended to provide an environment with controlled temperature, CO2
• 04779041940465 - Multi-zone ART Workstation: 2026-01-22 The Multi-zone ART Workstation is a laminar flow workstation intended to work with gametes and/or embryos at or near body temper
• 04779041940472 - Multi-zone ART Workstation: 2026-01-22 The Multi-zone ART Workstation is a laminar flow workstation intended to work with gametes and/or embryos at or near body temper
• 04779041940496 - Multi-zone ART Workstation: 2026-01-22 The Multi-zone ART Workstation is a laminar flow workstation intended to work with gametes and/or embryos at or near body temper
• 04779041940502 - Multi-zone ART Workstation: 2026-01-22 The Multi-zone ART Workstation is a laminar flow workstation intended to work with gametes and/or embryos at or near body temper
• 04779041940519 - Multi-zone ART Workstation: 2026-01-22 The Multi-zone ART Workstation is a laminar flow workstation intended to work with gametes and/or embryos at or near body temper
• 04779041940526 - Multi-zone ART Workstation: 2026-01-22 The Multi-zone ART Workstation is a laminar flow workstation intended to work with gametes and/or embryos at or near body temper