AccessGUDID - DEVICE: MR Patient Care Temperature Sensor Jacket (10884838111407)

GUDID

Device Identifier (DI) Information

Brand Name: MR Patient Care Temperature Sensor Jacket
Version or Model: Temperature Sensor Jacket
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803178181
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 10884838111407
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

Device Description: Disposable Flex Temp Jacket is designed for use with the FlexTEMP System, Sensor. The FlexTEMP Jacket must be used with the FlexTEMP Sensor while measuring Body temperature. This Sensor should also be used for surface temperature to reduce the occurrence of infection

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:	Yes
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?
13116	Electronic thermometer probe cover	A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use 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: Yes
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: 2483769f-957b-474e-8a5a-d3a4828b6b68
Public Version Date: June 09, 2025
Public Version Number: 1
DI Record Publish Date: May 30, 2025