AccessGUDID - DEVICE: IVUS-PIM (00845225012762)

GUDID

Device Identifier (DI) Information

Brand Name: IVUS-PIM
Version or Model: 802143001-ROHS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 802143001-ROHS
Company Name: Philips Image Guided Therapy Corporation

Primary DI Number: 00845225012762
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018860556 *Terms of Use

Device Description: Patient interface module for intravascular ultrasound catheters

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?
40763	Cardiovascular ultrasound imaging system	An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)
DSK	Computer, Blood-Pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190078	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
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between -18 and 60 Degrees Celsius
Storage Environment Humidity: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 58566f44-5c7f-43f4-bf44-04b8511aa58f
Public Version Date: April 01, 2025
Public Version Number: 1
DI Record Publish Date: March 24, 2025