Duns Number:687910463
Device Description: FREND System is designed for reding the FREND cartridge of a quantitative.
Catalog Number
F10
Brand Name
FREND
Version/Model Number
FREND System
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
K124056
Product Code
KHO
Product Code Name
Fluorometer, For Clinical Use
Public Device Record Key
93f981f1-22b6-47a1-9a49-63b89f709ba5
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 04, 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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |