DEVICE: BioGuard (00724995180539)

Device Identifier (DI) Information

BioGuard
00711780
In Commercial Distribution
00711780
US Endoscopy
00724995180539
GS1

1
627879687 *Terms of Use
00816765012772
The single use BioGuard air water valve, Olympus is used to control the air water function of an endoscope during GI endoscopic procedures.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FDF Colonoscope and accessories, flexible/rigid
ODC Endoscope channel accessory
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

34f8ada0-f878-4530-9310-713b58044de0
May 31, 2023
3
April 01, 2020
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)548-4873
xx@xx.xx
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