Duns Number:427395277
Device Description: Clinical Chemistry Test Systems / Chloride test system. A chloride test system is a devic Clinical Chemistry Test Systems / Chloride test system. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Catalog Number
5203
Brand Name
CL ELECTRODE, ISE MODULE
Version/Model Number
Cl- 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"
-
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
CGZ
Product Code Name
Electrode, Ion-Specific, Chloride
Public Device Record Key
0da47eb8-8c23-4978-b5d5-35268ac662fb
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
October 06, 2016
Package DI Number
15999883586706
Quantity per Package
1
Contains DI Package
05999883586709
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 |