AccessGUDID - DEVICE: Arterial Line Kit (00886333215744)

GUDID

Device Identifier (DI) Information

Brand Name: Arterial Line Kit
Version or Model: 498440
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 498440
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333215744
Issuing Agency: GS1
Commercial Distribution End Date: January 06, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: 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?
65100	Vascular catheterization support/maintenance kit, medicated	A collection of non-dedicated devices which includes a pharmaceutical agent intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes [in addition to the pharmaceutical agent(s)] devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter nor catheter introduction device are included. 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: f3cb34f1-d6ac-41f0-8667-934f4137538f
Public Version Date: January 07, 2025
Public Version Number: 4
DI Record Publish Date: September 21, 2016