Vessel Cannula, 3mm

Basic Information

• Brand Name: Vessel Cannula, 3mm
• Primary DI: 20634624533039
• Version / Model: VCC-03
• Catalog Number: VCC-03
• Company Name: QUEST MEDICAL INC
• Labeler DUNS: 041810693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-06-07
• Public Version: 4
• Public Version Date: 2019-11-13
• Public Version Status: Update
• Public Device Record Key: 61f53f5a-f515-4d44-bcd8-0bb9db348799

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47043	Intravascular occluding solution kit	A collection of sterile devices intended as an alternative to vascular clamping to interrupt local blood flow through transient intraluminal obstruction during surgery, suturing of blood vessels, or interventional vascular procedures. It includes a liquid polymer (e.g., poloxamer) that is injected into a vein/artery, and devices to contain/administer the solution (e.g., pouch, syringe, injection cannula or catheter). The solution typically has reverse thermal characteristics (i.e., liquid at room temperature and gelled at body temperature) enabling the formation of an in vivo plug that occludes the vessel; it eventually dissolves or is purposely dissolved. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20634624533039	GS1
Unit of Use	00634624533035	GS1

Premarket Submissions

Submission Number	Supplement Number
K971928	000