Duns Number:112942404
Device Description: Na/K/Cl/Ca/Li Solution pack for use with EasyLyte analyzers
Catalog Number
2124
Brand Name
Na/K/Cl/Ca/Li Solution pack
Version/Model Number
2124
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
K152327
Product Code
JFP
Product Code Name
Electrode, Ion Specific, Calcium
Public Device Record Key
0c7b17eb-4fda-44ea-9076-eaeddacd53cf
Public Version Date
January 07, 2019
Public Version Number
1
DI Record Publish Date
December 05, 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 |