Duns Number:052423787
Device Description: The Take-up tubes are intended to be used with the 3120 SWEAT•CHEK Sweat Conductivity Anal The Take-up tubes are intended to be used with the 3120 SWEAT•CHEK Sweat Conductivity Analyzer for sweat analysis for the laboratory diagnosis of cystic fibrosis. The tubes allow for a sweat specimen as small as 6 to 10 microliters to be measured.
Catalog Number
-
Brand Name
Take-up Tubes, 14 inch, Qty 100
Version/Model Number
SS-044
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
K863395
Product Code
CGZ
Product Code Name
Electrode, Ion-Specific, Chloride
Public Device Record Key
5a7988d6-a9a7-4a85-92e1-bdbc1003dfb8
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
February 19, 2021
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 |