AccessGUDID - DEVICE: PHILIPS IntelliVue Tympanic Temperature Module (00884838038615)

GUDID

Device Identifier (DI) Information

Brand Name: PHILIPS IntelliVue Tympanic Temperature Module
Version or Model: Tympanic Temperature Module
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 866149
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 00884838038615
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

Device Description: Tympanic Temperature Module for measuring spot-check temperature in the ear for neonates, pediatric and adult patients. The result of this measurement can be automatically adjusted to correspond to a different body reference site: Ear, Oral, Core and Rectal. The Module is compatible with IntelliVue Patient Monitors MP5SC/MP5-MP90 and MX400-MX800 and Avalon Fetal Monitors. Please check software requirements for compatibility. Package includes measurement device, holder for mounting on the table, on the wall or on the roll stand and starter pack of 96 covers.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
17887	Infrared patient thermometer, ear	A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: edfd6491-7781-4f71-9ee1-74a30fe02624
Public Version Date: March 08, 2022
Public Version Number: 6
DI Record Publish Date: November 22, 2016