Duns Number:752103403
Device Description: Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Co Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables multiple users to access and review patient/embryo data, using a Chrome browser on their PC workstations.
Catalog Number
-
Brand Name
Geri Software Connect and Assess 1.3
Version/Model Number
GERI-SCA-04
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
K180188
Product Code
MQG
Product Code Name
Accessory, Assisted Reproduction
Public Device Record Key
28ebe508-0693-4615-b01c-867245231b92
Public Version Date
April 23, 2019
Public Version Number
2
DI Record Publish Date
June 19, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |