AccessGUDID - DEVICE: FUJIFILM (04547410331011)

GUDID

Device Identifier (DI) Information

Brand Name: FUJIFILM
Version or Model: EG-450PE5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410331011
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 a medical Endoscope for the upper digestive tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb at medical facilities under management of physicians.

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):	No
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?
38805	Flexible video gastroduodenoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It can be end-viewing (looking forward) or side-viewing (looking to one side) and is used for the cannulation of the pancreas and bile duct. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDS	Gastroscope and accessories, flexible/rigid

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: Yes

Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify: There must be no condensation.
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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: fc7e13b2-8100-4216-a100-3b9f37e6614b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 14, 2016