DEVICE: FUJIFILM (04547410330960)

Download: XML | JSON

Device Identifier (DI) Information

FUJIFILM
EN-450T5

FUJIFILM CORPORATION
04547410330960
GS1
1
This product is a medical Endoscope for the small intestine. It is intended for observation, diagnosis, and endoscopic treatment of the small intestine at medical facilities under management of physicians.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Flexible video enteroscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (the duodenum, jejunum, and ileum). It is inserted into the body through the mouth or the anus during enteroscopy. It may be of a push-type, introduced by guidance under direct vision, or of a sonde type, which has an inflatable balloon that pulls it through the length of the intestine by peristalsis. 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. This reusable device is used to examine strictures, Crohn's disease, or take biopsies.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FDA Enteroscope and accessories
CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
High-level Disinfectant
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
December 14, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
14547410330967 1 04547410330960 In Commercial Distribution Box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+018002728465
xxx@xxx.xxx
CLOSE