20G 8CM Stiletto Extended Dwell Catheter

Basic Information

• Brand Name: 20G 8CM Stiletto Extended Dwell Catheter
• Primary DI: 00850042365052
• Version / Model: PIP200000
• Company Name: Avia Vascular, LLC
• Labeler DUNS: 106772781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-25
• Public Version: 1
• Public Version Date: 2024-07-03
• Public Version Status: New
• Public Device Record Key: 6de8ccac-4df1-42c2-8ec2-b0de4b099dd8

Device Description

The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or administer fluids over a short duration (<28 days) through a peripherally inserted catheter. The Stiletto EDC utilizes an introducer needle and sheathing cannula to support advancement of a single lumen, power-injectable catheter into peripheral vasculature. Unique catheter tip geometry is employed that works in conjunction with a sheathing cannula to provide support as the catheter advances into the vessel, providing a reliable method of insertion without need of a guidewire. The catheter, hub, and insertion components are integrated into a single housing to enhance ease of use.

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
PND	Midline Catheter	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64574	Peripheral intravenous cannula	A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850042365059	GS1	Inner Pack	10	In Commercial Distribution
Primary	00850042365052	GS1
Package	20850042365056	GS1	Case	2	In Commercial Distribution
Previous	00850051842001	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K210047	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.1	Millimeter
Catheter Length	80	Millimeter