Duns Number:427395277
Device Description: Clinical Chemistry Test Systems / Sodium test system. A sodium test system is a device in Clinical Chemistry Test Systems / Sodium test system. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Catalog Number
5201
Brand Name
NA ELECTRODE, ISE MODULE
Version/Model Number
NA+ Electrode
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101741,K101741
Product Code
JGS
Product Code Name
Electrode, Ion Specific, Sodium
Public Device Record Key
574916fc-a365-403c-8185-7c4f8a323d42
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
October 06, 2016
Package DI Number
15999883586683
Quantity per Package
1
Contains DI Package
05999883586686
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |