DEVICE: BioGuard (00724995180560)
Device Identifier (DI) Information
BioGuard
00711785
In Commercial Distribution
00711785
US Endoscopy
00711785
In Commercial Distribution
00711785
US Endoscopy
The BioGuard valves and air/water cleaning adapter kit is used to control the suction function of an endoscope during GI endoscopic procedures. 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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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60760 | Endoscope channel support kit |
A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.
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Active | false |
60758 | Endoscope air/water valve, single-use |
A device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] for insufflation, and/or water for irrigation, whilst preventing backflow. It is in the form of an attachable inflow valve with closed and open settings. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NWU | Endoscope introducer kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
45c15607-1b54-447b-9dbc-aac7ea3c20e4
July 25, 2024
3
August 12, 2020
July 25, 2024
3
August 12, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10724995180567 | 50 | 00724995180560 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)548-4873
xx@xx.xx
xx@xx.xx