AngioVac

Basic Information

• Brand Name: AngioVac
• Primary DI: H787800156250
• Version / Model: 80015625
• Company Name: NAVILYST MEDICAL, INC.
• Labeler DUNS: 809699023
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-10
• Public Version: 3
• Public Version Date: 2022-12-12
• Public Version Status: Update
• Public Device Record Key: cc06058d-0fab-4a45-8785-c90103c42d45
• Distribution End Date: 2022-12-09

Device Description

AngioVac Sheath Sidearm Assembly

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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
34905	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous	A semi-rigid or rigid tube intended to be surgically inserted into the right atrium or large vein to serve as a channel for the extracorporeal transport of deoxygenated blood from a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	15051684023429	GS1
Primary	H787800156250	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]