DEVICE: Disposable Biopsy Valve (06970401817139)

Device Identifier (DI) Information

Disposable Biopsy Valve
MD-A-BV02
In Commercial Distribution

Zhejiang Chuangxiang Medical Technology Co., LTD.
06970401817139
GS1

1
544434963 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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?
62145 Endoscope working-channel valve, single-use
A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OCX Endoscopic Irrigation/Suction System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K173758 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4fed3db5-e59e-4c3d-bcb8-70dae114064c
July 25, 2024
4
August 26, 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
16970401817174 100 06970401817139 In Commercial Distribution Box
26970401817188 5 16970401817174 In Commercial Distribution Case
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Secondary DI

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

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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
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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