DEVICE: Disposable Hemodialysis Access Catheter Set Double Lumen12F*16cm(Straight) (06938634491083)

Device Identifier (DI) Information

Disposable Hemodialysis Access Catheter Set Double Lumen12F*16cm(Straight)
R5Z-FR-2255
In Commercial Distribution

Guangdong Baihe Medical Technology Co., Ltd.
06938634491083
GS1

1
547055364 *Terms of Use
No description.
CLOSE

Device Characteristics

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

FDA Product Code

[?]
Product Code Product Code Name
MPB Catheter, Hemodialysis, Non-Implanted
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102833 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

6e6454c6-8ea4-41ae-a20d-335891ae34b6
July 06, 2018
3
September 22, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
26938634491087 40 16938634491080 In Commercial Distribution
16938634491080 10 06938634491083 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE