AccessGUDID - DEVICE: FUJIFILM (04547410446104)

GUDID

Device Identifier (DI) Information

Brand Name: FUJIFILM
Version or Model: EX-0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410446104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 713565195 *Terms of Use

Device Description: The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states. This product may be used on all patients requiring endoscopic examination when using a Fujinon/FUJIFILM medical endoscope, video processor and light source together with monitor, recorder and various peripheral devices. The prospective clinical value of measurements made with OXEI has not been demonstrated in disease states.

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:	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?
46615	Tissue saturation oximeter	A mains electricity (AC-powered) photoelectric device that noninvasively calculates the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTN	Led Light Source
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
GCJ	Laparoscope, General & Plastic Surgery
MUD	Oximeter, Tissue Saturation
NWB	Endoscope, Accessories, Narrow Band Spectrum
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement

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
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Special Storage Condition, Specify: There must be no condensation.
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 82921b14-94c1-4fa3-a126-2d6ad7fa7158
Public Version Date: December 02, 2024
Public Version Number: 4
DI Record Publish Date: September 29, 2021