AccessGUDID - DEVICE: Genius 2 (20884838028726)

GUDID

Device Identifier (DI) Information

Brand Name: Genius 2
Version or Model: 989803179611
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 989803179611
Company Name: Philips Medical Systems Hsg

Primary DI Number: 20884838028726
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: Genius 2 Probe Cover (CE marked)

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):	No
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?
33586	General-purpose multi-parameter bedside monitor	An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)
DSF	Recorder, Paper Chart
DSJ	Alarm, Blood-Pressure
DSK	Computer, Blood-Pressure
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function
DXN	System, Measurement, Blood-Pressure, Non-Invasive
FLL	Thermometer, Electronic, Clinical

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
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Temperature: between -4 and 104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 70 and 101 KiloPascal
Storage Environment Humidity: between 15 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1339aff-3b8e-453b-bab4-7094c80968be
Public Version Date: January 18, 2023
Public Version Number: 10
DI Record Publish Date: October 05, 2016