Duns Number:691795268
Device Description: This equipment is designed for providing an environment with controlled temperature, CO2, This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
Catalog Number
-
Brand Name
PHCbi
Version/Model Number
MCO-5M-PA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2021
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQG
Product Code Name
Accessory, Assisted Reproduction
Public Device Record Key
9878d78a-747e-4e52-b633-68eb89d3b6ff
Public Version Date
April 08, 2021
Public Version Number
5
DI Record Publish Date
April 25, 2018
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. | 16 |