Duns Number:052423787
Device Description: For use with Macroduct Sweat Collection System to attach electrodes and collectors used to For use with Macroduct Sweat Collection System to attach electrodes and collectors used to induce and collect sweat for diagnosis of Cystic Fibrosis.
Catalog Number
-
Brand Name
Macroduct® Black Electrode Strap, Qty 1
Version/Model Number
RP-381
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"
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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
-
Product Code
KTB
Product Code Name
Device, Iontophoresis, Specific Uses
Public Device Record Key
7be73943-8230-47d5-b743-975c8b54e41c
Public Version Date
February 26, 2021
Public Version Number
1
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 |