DEVICE: BioGuard (00724995180539)
Device Identifier (DI) Information
BioGuard
00711780
In Commercial Distribution
00711780
US Endoscopy
00711780
In Commercial Distribution
00711780
US Endoscopy
The single use BioGuard air water valve, Olympus is used to control the air water function of an endoscope during GI endoscopic procedures.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
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? |
---|---|---|---|---|
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FDF | Colonoscope and accessories, flexible/rigid |
ODC | Endoscope channel accessory |
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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Special Storage Condition, Specify: Keep Dry |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
34f8ada0-f878-4530-9310-713b58044de0
May 31, 2023
3
April 01, 2020
May 31, 2023
3
April 01, 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 |
---|---|---|---|---|---|
10724995180536 | 50 | 00724995180539 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
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