AccessGUDID - DEVICE: FUJIFILM (04547410520910)

GUDID

Device Identifier (DI) Information

Brand Name: FUJIFILM
Version or Model: CT-2LT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410520910
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 check whether the FUJIFILM Leak Tester LT-100 can properly test the airtightness of a FUJIFILM endoscope. Do not use this product for any other purposes.

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?
64509	Endoscope leak tester tubing	A length of flexible tube with connectors intended to deliver a medium (typically air) from a leak tester to the interior of an endoscope during a leak test; it may in addition be intended for other endoscope pre- or post-procedural processing (e.g., allow connection of a fluid seal). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCY	Bulb, Inflation, For Endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 67a67769-9028-4be0-9550-0fb3ee3314b2
Public Version Date: June 11, 2024
Public Version Number: 2
DI Record Publish Date: December 15, 2023