AccessGUDID - DEVICE: FUJIFILM (04547410446142)

GUDID

Device Identifier (DI) Information

Brand Name: FUJIFILM
Version or Model: BS-102
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410446142
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 713565195 *Terms of Use

Device Description: This product is intended to be used in combination with the FUJIFILM ultrasonic endoscope to enclose the ultrasonic transmission medium in medical facilities under the management of physicians. Do not use this product for any other purpose. This product is not intended for use on children and infants.

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:	Yes
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?
62177	Ultrasound endoscope balloon, synthetic polymer	A sterile balloon-like cap made of a synthetic-polymer (e.g., silicone) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology
FDS	Gastroscope And Accessories, Flexible/Rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221238	000

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 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 85 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: f9fecaaa-285c-45e4-81b7-9a2fcf20eb22
Public Version Date: November 02, 2023
Public Version Number: 2
DI Record Publish Date: September 19, 2022