Duns Number:052423787
Device Description: ELITechGroup's calibrator solution is for calibration of the Sweat-Chek™ Sweat Conductivit ELITechGroup's calibrator solution is for calibration of the Sweat-Chek™ Sweat Conductivity Analyzer.
Catalog Number
-
Brand Name
Sweat-Chek™ Calibrator, 90 mmol/L, 60 x 0.75mL
Version/Model Number
SS-140
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
-
Product Code
JIS
Product Code Name
Calibrator, Primary
Public Device Record Key
6c86b3ce-a57a-4129-ab5a-14d67ea89c86
Public Version Date
October 22, 2020
Public Version Number
1
DI Record Publish Date
October 14, 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 | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |