NovaPort cannula

Basic Information

• Brand Name: NovaPort cannula
• Primary DI: 04260058550728
• Version / Model: NovaPort® one Vascular Access and Introducer Kit
• Catalog Number: 8800077
• Company Name: novalung GmbH
• Labeler DUNS: 331791694
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-30
• Public Version: 4
• Public Version Date: 2020-12-17
• Public Version Status: Update
• Public Device Record Key: a2c46016-dc9c-46a2-b58d-7ced9cee48da
• Distribution End Date: 2018-12-31

Device Description

The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a cone without wire reinforcement where the cannulas can be clamped. The NovaPort® one cannulas are inserted percutaneously (Seldinger technique) into vessels. All necessary accessories are delivered with the product.

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
47733	Cardiopulmonary bypass cannula, femoral	A sterile, rigid or semi-rigid tube designed to be inserted into a femoral artery or vein during cardiopulmonary bypass procedures. It is typically a 9 to 24 Fr tube with an end hole (some may include side holes); it is short enough to keep the distal tip inside the femoral vessel. The tube is used in set-ups/systems intended to divert the patient's blood to and from external tubing and an arterial pump, bypassing the heart and lungs completely. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260058550728	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	13	French

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 86 Degrees Fahrenheit