Duns Number:201179681
Device Description: The epoc Blood Analysis System, is intended for use by trained medical professionals as an The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratoryor at the point of care in hospitals, nursing homes or other clinical care institutions.
Catalog Number
16266
Brand Name
epoc NXS Host
Version/Model Number
11413475
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
K200107
Product Code
CEM
Product Code Name
ELECTRODE, ION SPECIFIC, POTASSIUM
Public Device Record Key
077a07f6-60de-462a-9ee1-21d1c23d2750
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
June 18, 2020
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 | 25 |