Duns Number:052423787
Device Description: For use with Macroduct Sweat Collection System to induce sweat for diagnosis of Cystic Fib For use with Macroduct Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
Catalog Number
-
Brand Name
Macroduct® Advanced Electrode Cable Assembly
Version/Model Number
RP-537
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 07, 2021
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
K180627
Product Code
KTB
Product Code Name
Device, Iontophoresis, Specific Uses
Public Device Record Key
f0c9d654-7634-4c9d-b981-fbd1e1fea1bf
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
February 18, 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 |