AccessGUDID - DEVICE: FUJIFILM (04547410331592)

GUDID

Device Identifier (DI) Information

Brand Name: FUJIFILM
Version or Model: GW-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410331592
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 713565195 *Terms of Use

Device Description: This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm’s endoscopy system.

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?
41617	Gastrointestinal endoscopic insufflator	A mains electricity (AC-powered) device intended to be used during an endoscopic procedure to distend (expand by pressure) the lumen of the colon or other portion of the gastrointestinal (GI) tract, and/or improve endoscopic visualization (e.g., prevent dew/mist accumulating at the lens) through the pressure-limited introduction of medical gas [e.g., carbon dioxide (CO2)]. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. This device may also be referred to as a gas distention system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCX	INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133976	000
K180711	000

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 Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -10 and 45 Degrees Celsius
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 30 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: There must be no condensation.
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ff8f473-7747-493a-a961-27b82e461271
Public Version Date: June 11, 2024
Public Version Number: 5
DI Record Publish Date: December 14, 2016