DEVICE: Disposable Biopsy Valve (06970401813520)

Device Identifier (DI) Information

Disposable Biopsy Valve
MD-B-BV01
In Commercial Distribution

Zhejiang Chuangxiang Medical Technology Co., LTD.
06970401813520
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?
60757 Endoscopic biopsy valve, sterile
A sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include a water input valve for simultaneous irrigation/biopsy. This is a single-use device.
Obsolete 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

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

[?]
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

8775912c-0cc9-44db-8b4f-b214d6164ca3
July 18, 2022
3
December 03, 2018
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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
26970401813548 5 16970401813534 In Commercial Distribution Case
16970401813534 100 06970401813520 In Commercial Distribution Box
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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

[?]
No Customer Contact currently defined
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