AccessGUDID - DEVICE: Azurion (00884838099234)

GUDID

Device Identifier (DI) Information

Brand Name: Azurion
Version or Model: Azurion 5 M20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 722228
Company Name: Philips Medical Systems Nederland B.V.

Primary DI Number: 00884838099234
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 413819707 *Terms of Use

Device Description: Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inch flat detector.

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:	No
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?
37623	Stationary angiographic x-ray system, digital	A stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWB	Interventional Fluoroscopic X-Ray System
JAA	System, X-Ray, Fluoroscopic, Image-Intensified

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200917	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 696a59b5-738c-4df6-96eb-046f48e9457c
Public Version Date: September 26, 2023
Public Version Number: 2
DI Record Publish Date: May 26, 2020