AccessGUDID - DEVICE: FUJIFILM (04547410324280)

GUDID

Device Identifier (DI) Information

Brand Name: FUJIFILM
Version or Model: TY-500D
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410324280
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 the tube kit used in combination with the compatible balloon controller in medical facilities . Do not use this product for any other purpose The product consists of a tube for connection to the endoscope and over-tube and balloon controller, and a filter. This product is supplied non-sterile. Also, The filter is a single patient use item. Prepare a new filter before use.

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?
40484	Medical air low pressure hose	A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed medical air from a medical air cylinder/terminal unit to a medical device that functions with medical air (e.g., ventilator, anaesthesia unit, anaesthesia system, suctions system, or other medical air dependent device). The gas pressure in the tubing will be low, a "working pressure", having been reduced by a regulator from a higher pressure. The tubing is reinforced with, e.g., woven polyester or cotton and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDF	Colonoscope And Accessories, Flexible/Rigid
FDA	Enteroscope And Accessories

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
Moist Heat or Steam Sterilization
Ethylene Oxide

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ee0a8291-47ef-4c68-8482-167e5e5adc56
Public Version Date: June 10, 2024
Public Version Number: 2
DI Record Publish Date: February 06, 2023