FUJIFILM

Basic Information

• Brand Name: FUJIFILM
• Primary DI: 04547410467284
• Version / Model: BS-4
• Company Name: FUJIFILM CORPORATION
• Labeler DUNS: 713565195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-06
• Public Version: 4
• Public Version Date: 2025-12-01
• Public Version Status: Update
• Public Device Record Key: 7b3b6cce-d619-438f-b67a-944e995dae09

Device Description

This product is used in combination with FUTIFILM Double Balloon Endoscopes at medical facilities under the management of physicians. Being attached to the endoscope, this product is inserted into the digestive tract from the mouth or anus to stabilize the distal end of the endoscope to the digestive tract's mucous membrane. Do not use this product for any other purposes. This product is not intended for use for any neonates , infants or children

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2
FDA	Enteroscope And Accessories	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45712	Gastrointestinal/biliary dilation balloon catheter, non-medicated	A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14547410467281	GS1	Box	10	In Commercial Distribution
Primary	04547410467284	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K223295	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Stored in a package box
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: There must be no condensation.
• Type: Storage Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 30 – 95 Percent (%) Relative Humidity