AccessGUDID - DEVICE: Expression MR FlexTEMP II Sensor (00884838056077)

GUDID

Device Identifier (DI) Information

Brand Name: Expression MR FlexTEMP II Sensor
Version or Model: FlexTEMP II Sensor
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 989803194511
Company Name: Philips Ds North America LLC

Primary DI Number: 00884838056077
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 013649151 *Terms of Use

Device Description: Temperature sensor for Expression MRI patient monitors, capable of surface measurement or, with applied FlexTEMP Jacket, esophogeal/nasal/rectal body temperature.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
14034	Continuous electronic patient thermometer, battery-powered	A battery-powered, electronic instrument designed to continuously measure (monitor) a patient's body temperature (e.g., during the administration of general anaesthesia, treatment of hypothermia and hyperthermia). It comprises an electronic unit and an attached probe that detects and converts the changes in temperature into variations of an electric characteristic, e.g., resistance or voltage. These variations of the electric characteristic are processed in the electronic circuits and continuously displayed as temperature readings. This is a reusable device.	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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 5 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e1ac5ac5-9f3a-4e5a-a742-7ec4830076bb
Public Version Date: June 02, 2025
Public Version Number: 8
DI Record Publish Date: December 12, 2016