AccessGUDID - DEVICE: FUJIFILM (04547410330151)

GUDID

Device Identifier (DI) Information

Brand Name: FUJIFILM
Version or Model: EB-530T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410330151
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 713565195 *Terms of Use

Device Description: This device is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree. This device may be used on adults, adolescents and children requiring endoscopic examination and as deemed appropriate by trained medical professionals.

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

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

GMDN Preferred Term Name	GMDN Definition
Flexible video bronchoscope, reusable	An endoscope with a flexible inserted portion for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Flexible video bronchoscope, reusable

An endoscope with a flexible inserted portion for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
EOQ	BRONCHOSCOPE (FLEXIBLE OR 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 [?]
Ethylene Oxide
High-level Disinfectant

Storage and Handling

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

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7276c487-a34e-4d64-8acf-8f03c1ba9e3d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 14, 2016