DEVICE: Disposable Hemodialysis Access Catheter Set Double Lumen14F*16cm(Cruved) (06938634496378)
Device Identifier (DI) Information
Disposable Hemodialysis Access Catheter Set Double Lumen14F*16cm(Cruved)
R2W-FR-2415
In Commercial Distribution
Guangdong Baihe Medical Technology Co., Ltd.
R2W-FR-2415
In Commercial Distribution
Guangdong Baihe Medical Technology Co., Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MPB | Catheter, Hemodialysis, Non-Implanted |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K102833 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
78aa9a0e-910a-4bcb-8f7e-fad6cc4bcc67
July 06, 2018
3
September 20, 2016
July 06, 2018
3
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
26938634496372 | 40 | 16938634496375 | In Commercial Distribution | ||
16938634496375 | 10 | 06938634496378 | In Commercial Distribution |
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
[?]
No Customer Contact currently defined