MIRI TL

GUDID 04779041940113

To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted mic

AT MEDICAL UAB

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• Primary Device ID: 04779041940113
• NIH Device Record Key: f2ea7fd4-6ec6-4a53-bcff-6c8426e8b193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIRI TL
• Version Model Number: MIRI TL
• 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	04779041940113 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-13

Devices Manufactured by AT MEDICAL UAB

• 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: 2018-03-29To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted mic
• 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