MIRI

GUDID 04779041940106

The incubator is a new generation of desktop CO2 and O2 incubator used for maintaining an optimal environment for the development of Embryos and Blast

AT MEDICAL UAB

Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator

• Primary Device ID: 04779041940106
• NIH Device Record Key: aa48df9a-8ead-4262-a035-c9533f8187f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIRI
• Version Model Number: MIRI
• Company DUNS: 365831125
• Company Name: AT MEDICAL 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: false
• 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	04779041940106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133742

FDA Product Code

• MQG: Accessory, Assisted Reproduction

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-13

Devices Manufactured by AT MEDICAL UAB

• 04779041940106 - MIRI: 2018-07-06The incubator is a new generation of desktop CO2 and O2 incubator used for maintaining an optimal environment for the development of Embryos and Blast
• 04779041940106 - MIRI: 2018-07-06 The incubator is a new generation of desktop CO2 and O2 incubator used for maintaining an optimal environment for the developmen
• 04779041940113 - MIRI TL: 2018-03-29 To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an i