Duns Number:365831125
Device Description: The incubator is a new generation of desktop CO2 and O2 incubator used for maintaining an The incubator is a new generation of desktop CO2 and O2 incubator used for maintaining an optimal environment for the development of Embryos and Blastocysts.
Catalog Number
-
Brand Name
MIRI
Version/Model Number
MIRI
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133742
Product Code
MQG
Product Code Name
Accessory, Assisted Reproduction
Public Device Record Key
aa48df9a-8ead-4262-a035-c9533f8187f6
Public Version Date
September 14, 2020
Public Version Number
4
DI Record Publish Date
October 13, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |