Duns Number:071595540
Device Description: CleanGuard Disposable Endoscope Valves Set, Contains Air/Water Valve, Suction Valve and Bi CleanGuard Disposable Endoscope Valves Set, Contains Air/Water Valve, Suction Valve and Biopsy Valve
Catalog Number
200305
Brand Name
CleanGuard
Version/Model Number
200305
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
OCX
Product Code Name
endoscopic irrigation/suction system
Public Device Record Key
3fae2b66-6c0b-4de3-97df-3e71c0a1fcb8
Public Version Date
April 15, 2019
Public Version Number
1
DI Record Publish Date
April 06, 2019
Package DI Number
30653405986472
Quantity per Package
200
Contains DI Package
20653405986475
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |