Disposable Hemodialysis Access Catheter Set Double Lumen12F*16cm(Cruved)

Basic Information

• Brand Name: Disposable Hemodialysis Access Catheter Set Double Lumen12F*16cm(Cruved)
• Primary DI: 06938634491731
• Version / Model: G2W-FR-2215
• Company Name: Guangdong Baihe Medical Technology Co., Ltd.
• Labeler DUNS: 547055364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 5
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: c87b17c0-36ce-4beb-b7b9-0038661e8c57

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
10729	Centrally-inserted central venous catheter	A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26938634491735	GS1		40	In Commercial Distribution
Package	16938634491738	GS1		10	In Commercial Distribution
Primary	06938634491731	GS1

Premarket Submissions

Submission Number	Supplement Number
K102833	000