20G 8CM Stiletto Extended Dwell Catheter

GUDID 10850042365059

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.

Avia Vascular, LLC

Peripheral intravenous cannula
Primary Device ID10850042365059
NIH Device Record Key6de8ccac-4df1-42c2-8ec2-b0de4b099dd8
Commercial Distribution StatusIn Commercial Distribution
Brand Name20G 8CM Stiletto Extended Dwell Catheter
Version Model NumberPIP200000
Company DUNS106772781
Company NameAvia Vascular, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com
Phone(801) 824-5375
Emailinfo@avia-vascular.com

Device Dimensions

Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850042365052 [Primary]
GS100850051842001 [Previous]
GS110850042365059 [Package]
Contains: 00850042365052
Package: Inner Pack [10 Units]
In Commercial Distribution
GS120850042365056 [Package]
Package: Case [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNDMidline Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-03
Device Publish Date2024-06-25

Devices Manufactured by Avia Vascular, LLC

10850042365059 - 20G 8CM Stiletto Extended Dwell Catheter2024-07-03The 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 (
10850042365059 - 20G 8CM Stiletto Extended Dwell Catheter2024-07-03 The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or admini
00850042365007 - 20G Open-System Ally Blood Collection Device2022-11-01
00850042365014 - 22G Open-System Ally Blood Collection Device2022-11-01
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