AccessGUDID - DEVICE: Argon Arterial Line Kit (00886333215621)

GUDID

Device Identifier (DI) Information

Brand Name: Argon Arterial Line Kit
Version or Model: 498405
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 498405
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333215621
Issuing Agency: GS1
Commercial Distribution End Date: April 16, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Argon Arterial Line Kit 18ga x 6"

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
10688	Angiographic catheter, single-use	A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDY	Gauze/Sponge, Internal, X-Ray Detectable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K780871	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
Device Size Text, specify: 18ga x 6"

Device Record Status

Public Device Record Key: 41817166-521a-4685-8f6f-086cd3867878
Public Version Date: April 17, 2024
Public Version Number: 4
DI Record Publish Date: September 20, 2016