DEVICE: MIRI TL (04779041940113)
Device Identifier (DI) Information
MIRI TL
MIRI TL
In Commercial Distribution
ESCO MEDICAL TECHNOLOGIES UAB
MIRI TL
In Commercial Distribution
ESCO MEDICAL TECHNOLOGIES UAB
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61195 | Assisted reproduction incubator/microscope camera system |
An assembly of mains electricity (AC-powered) devices intended to be used during assisted reproduction/in vitro fertilization (IVF) to incubate reproductive biological materials (e.g., gametes and embryos) at closely regulated and monitored temperatures, whilst acquiring, processing, and storing images of the embryo cultures, over the course of development, to assist embryo selection. It consists of an incubator with a built-in digital microscope still camera, monitor, and software; it may include additional supportive devices (e.g., printer). The system may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentrations].
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FDA Product Code
[?]Product Code | Product Code Name |
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MQG | Accessory, Assisted Reproduction |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K151357 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f2ea7fd4-6ec6-4a53-bcff-6c8426e8b193
December 18, 2023
4
October 13, 2016
December 18, 2023
4
October 13, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined