Duns Number:112942404
Device Description: Daily Cleaning Solution Kit for use with EasyStat, EasyBloodGas, EasyLyte and EasyElectrol Daily Cleaning Solution Kit for use with EasyStat, EasyBloodGas, EasyLyte and EasyElectrolyte Analyzers
Catalog Number
2118
Brand Name
Daily Cleaning Solution Kit
Version/Model Number
2118
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
K021515
Product Code
CEM
Product Code Name
Electrode, Ion Specific, Potassium
Public Device Record Key
85af9be6-deef-48c5-90d5-2c57eaadf293
Public Version Date
January 04, 2019
Public Version Number
1
DI Record Publish Date
December 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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 82 |