AccessGUDID - DEVICE: Contrast Line (00886333207442)

GUDID

Device Identifier (DI) Information

Brand Name: Contrast Line
Version or Model: 193360
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 193360
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333207442
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: Contrast Line 30"(75cm) M/F (Braided) 1200 PSI

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:	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?
44685	Radiographic procedure tubing	A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963749	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: 30"(75cm), 1200 PSI

Device Record Status

Public Device Record Key: 0631efe3-2e7a-49e8-8563-50e5e040e5a6
Public Version Date: April 17, 2024
Public Version Number: 4
DI Record Publish Date: September 09, 2016