MIRI Time-Lapse Incubator

GUDID 04779041940298

Esco Medical MIRI® TL family`s multiroom IVF incubators are intended to provide 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. The device use is limited up to six days (199 hours), covering the time from post-fertilization to day 6 of the development.

ESCO MEDICAL TECHNOLOGIES UAB

Aerobic laboratory incubator

• Primary Device ID: 04779041940298
• NIH Device Record Key: ba661ac4-5cea-433d-9d68-8398add0da54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIRI Time-Lapse Incubator
• Version Model Number: MIRI TL6
• Company DUNS: 365831125
• Company Name: ESCO MEDICAL TECHNOLOGIES UAB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	04779041940298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151357

FDA Product Code

• MQG: Accessory, Assisted Reproduction

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: 2026-01-22 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: 2026-01-22Esco Medical MIRI® TL family`s multiroom IVF incubators are intended to provide 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. The device use is limited up to six days (199 hours), covering the time from post-fertilization to day 6 of the development.
• 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