Duns Number:412925992
Device Description: Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, electroly Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 6 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.
Catalog Number
266.006.010
Brand Name
Eurotrol epoc GAS-ISE Metabolites
Version/Model Number
Level 6
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121468,K121468
Product Code
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
b41030b2-1355-4c21-9c62-4619ea116078
Public Version Date
August 13, 2018
Public Version Number
1
DI Record Publish Date
July 11, 2018
Package DI Number
08718734960782
Quantity per Package
10
Contains DI Package
08718734960799
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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. | 15 |