Duns Number:627879687
Device Description: The BioGuard valves (3-piece) and air/water cleaning adapter kit is used to control the su The BioGuard valves (3-piece) and air/water cleaning adapter kit is used to control the suction function of an endoscope during GI endoscopic procedures. The single use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus and G5 and newer Fujinon gastrointestinal endoscopes. The BioGuard air/water cleaning adapter is intended as part of the precleaning process to help clear the air/water channel of Olympus GI endoscopes post procedure.
Catalog Number
00711786
Brand Name
BioGuard
Version/Model Number
00711786
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
NWU
Product Code Name
Endoscope introducer kit
Public Device Record Key
2f594097-d030-475a-b40e-ac6e018791f7
Public Version Date
March 19, 2021
Public Version Number
3
DI Record Publish Date
August 12, 2020
Package DI Number
10724995180574
Quantity per Package
50
Contains DI Package
00724995180577
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 |