AccessGUDID - DEVICE: 20G 8CM Stiletto Extended Dwell Catheter (00850042365052)

GUDID

Device Identifier (DI) Information

Brand Name: 20G 8CM Stiletto Extended Dwell Catheter
Version or Model: PIP200000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Avia Vascular, LLC

Primary DI Number: 00850042365052
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106772781 *Terms of Use
Previous DI: 00850051842001

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PND	Midline Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210047	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.1 Millimeter
Catheter Length: 80 Millimeter

Device Record Status

Public Device Record Key: 6de8ccac-4df1-42c2-8ec2-b0de4b099dd8
Public Version Date: July 03, 2024
Public Version Number: 1
DI Record Publish Date: June 25, 2024