AccessGUDID - DEVICE: Philips Hemodynamic Application (00884838084544)

GUDID

Device Identifier (DI) Information

Brand Name: Philips Hemodynamic Application
Version or Model: Philips Hemodynamic Application - 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 002010
Company Name: Philips Medical Systems Nederland B.V.

Primary DI Number: 00884838084544
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 413819707 *Terms of Use

Device Description: Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment.

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?
42407	Haemodynamic monitoring system application software	An application software program intended to be used as part of a haemodynamic monitoring system to continuously collect, display, and record real-time cardiovascular physiology data [e.g., haemodynamic parameters, electrocardiogram (ECG), SpO2] to monitor a patient during cardiovascular catheterization procedures. It is not intended for bedside monitoring.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: bf0e6c6e-94de-4f87-93c5-b3ad99964c9e
Public Version Date: September 26, 2023
Public Version Number: 8
DI Record Publish Date: December 01, 2018