DEVICE: Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*13cm(Straight) (06938634491656)

Device Identifier (DI) Information

Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*13cm(Straight)
H2Z-FH-2114
In Commercial Distribution

Guangdong Baihe Medical Technology Co., Ltd.
06938634491656
GS1

1
547055364 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
No

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60879 Haemodialysis catheterization kit
A collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It includes a nonimplantable double-lumen haemodialysis catheter, device dedicated to catheter introduction/function (e.g., introducer needle, guidewire) and includes non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
MPB Catheter, Hemodialysis, Non-Implanted
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102833 000
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Sterilization

Yes
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

a837f7c3-9f32-425d-aad7-d7d0f9031494
July 06, 2018
3
September 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
26938634491650 40 16938634491653 In Commercial Distribution
16938634491653 10 06938634491656 In Commercial Distribution
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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