Duns Number:052423787
Device Description: The Macroduct System is intended for clinical laboratory use by qualified personnel for st The Macroduct System is intended for clinical laboratory use by qualified personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.
Catalog Number
Model 3710
Brand Name
Macroduct® Advanced 3710 Sweat Collection System
Version/Model Number
Model 3710
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
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
181ff4c5-5bdc-4984-beca-168f8623e74f
Public Version Date
February 23, 2021
Public Version Number
3
DI Record Publish Date
October 11, 2018
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 |