AccessGUDID - DEVICE: Disposable Hemodialysis Access Catheter Set Double Lumen8.5F*16cm(Straight) (06938634491816)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Hemodialysis Access Catheter Set Double Lumen8.5F*16cm(Straight)
Version or Model: R2Y-FR-2915
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Guangdong Baihe Medical Technology Co., Ltd.

Primary DI Number: 06938634491816
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 547055364 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
MPB	Catheter, Hemodialysis, Non-Implanted

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 09c73e85-943d-429e-a04c-a6413b370eee
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016