Duns Number:202659140
Device Description: The Acu-SinQ Complete Endoscope Cleaning Aid System is designed to provide support for aut The Acu-SinQ Complete Endoscope Cleaning Aid System is designed to provide support for automated leak testing, dosing, temperature monitoring, channel flushing, rinsing, and process documentation.
Catalog Number
AQSCOMP
Brand Name
Acu-SinQ
Version/Model Number
Acu-SinQ Complete
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FEB
Product Code Name
Accessories, cleaning, for endoscope
Public Device Record Key
add77ea6-7bc8-400e-b913-c0ce00af6263
Public Version Date
August 09, 2021
Public Version Number
4
DI Record Publish Date
February 28, 2019
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 262 |