AccessGUDID - DEVICE: PHILIPS IntelliVue TcG10 (00884838020764)

GUDID

Device Identifier (DI) Information

Brand Name: PHILIPS IntelliVue TcG10
Version or Model: IntelliVue TcG10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 865298
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 00884838020764
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

Device Description: IntelliVue TcG10 Gas Modul for external transcutaneous O2 and CO2 measurement

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?
46934	Transcutaneous blood gas monitoring system	An assembly of mains electricity (AC-powered) devices designed for the continuous and transcutaneous measurement of a patient's blood gas parameters, typically blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), haemoglobin oxygen saturation (SpO2), and/or venous blood oxygenation through the jugular vein (SjvO2); often with pulse rate. It consists primarily of a probe for gas detection (e.g., via transcutaneous gas diffusion, or using light spectroscopy) placed on the patient’s skin, and an oximetry monitor for the measurement, analysis, and display of data; patient adhesives and connecting cables may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKD	MONITOR, CARBON-DIOXIDE, CUTANEOUS

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 Atmospheric Pressure: between 57 and 106 KiloPascal
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f581ae5a-2d85-4b0d-9c9b-a6b218c68c0a
Public Version Date: July 24, 2024
Public Version Number: 6
DI Record Publish Date: December 15, 2016