Duns Number:627879687
Device Description: The DuoSwift cleaning brush- channel brush and squeegee combo is to only be used in channe The DuoSwift cleaning brush- channel brush and squeegee combo is to only be used in channels 2.8 ? 7.0 mm in diameter.
Catalog Number
00711618
Brand Name
Duoswift
Version/Model Number
00711618
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MNL
Product Code Name
ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
Public Device Record Key
a1e83830-1945-4347-9993-bc2ce84f7f28
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 31, 2021
Package DI Number
10724995185036
Quantity per Package
50
Contains DI Package
00724995185039
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |