Duns Number:796083392
Device Description: Ultra-Low Total Chlorine Test Strips - Fresenius
Catalog Number
K100-0118F
Brand Name
RPC
Version/Model Number
K100-0118F
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
Yes
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
K090338,K090338,K090338,K090338
Product Code
MSY
Product Code Name
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Public Device Record Key
1e11d95e-80fb-4b26-818f-b4005c5973fa
Public Version Date
August 16, 2019
Public Version Number
4
DI Record Publish Date
January 19, 2017
Package DI Number
30858293006046
Quantity per Package
22
Contains DI Package
20858293006049
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |