ABLE CENTRAL VENOUS CATHETER

Basic Information

• Brand Name: ABLE CENTRAL VENOUS CATHETER
• Primary DI: 06938634479210
• Version / Model: Triple Lumen 5.5F*5cm
• Catalog Number: FV-3521
• 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: 2016-09-22
• Public Version: 7
• Public Version Date: 2024-06-20
• Public Version Status: Update
• Public Device Record Key: fe2db98f-9dbc-45e9-87f6-c958a028beeb

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: No
• 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
FOZ	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61594	Central venous catheterization kit, short-term	A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26938634479214	GS1		40	In Commercial Distribution
Package	16938634479217	GS1		10	In Commercial Distribution
Primary	06938634479210	GS1

Premarket Submissions

Submission Number	Supplement Number
K070451	000