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-170MP-PA
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUB
Product Code Name
Accessory, Assisted Reproduction, Exempt
Public Device Record Key
7fe0520d-754e-4458-b6d2-a4cb240ccc49
Public Version Date
November 25, 2019
Public Version Number
1
DI Record Publish Date
November 15, 2019
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 |