20G 8CM Stiletto Extended Dwell Catheter

GUDID 00850051842001

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.

Slipstream Medical, LLC

Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula
Primary Device ID00850051842001
NIH Device Record Key8430203e-37e1-4fc5-b05d-452df32ce0a5
Commercial Distribution StatusIn Commercial Distribution
Brand Name20G 8CM Stiletto Extended Dwell Catheter
Version Model NumberPIP200000
Company DUNS121638194
Company NameSlipstream Medical, 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 Datefalse
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) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.com
Phone(801) 210-2452
Emailinfo@slipstreammedical.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
Outer Diameter1.1 Millimeter
Catheter Length80 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850051842001 [Primary]
GS100850051842049 [Package]
Contains: 10850051842008
Package: Case [2 Units]
In Commercial Distribution
GS110850051842008 [Package]
Package: Inner Pack [10 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 Date2024-02-13
Device Publish Date2024-02-05
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