FUJIFILM

Basic Information

• Brand Name: FUJIFILM
• Primary DI: 04547410432589
• Version / Model: BA-03
• Company Name: FUJIFILM CORPORATION
• Labeler DUNS: 713565195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-28
• Public Version: 1
• Public Version Date: 2022-10-06
• Public Version Status: New
• Public Device Record Key: a625bdf9-48d4-4fac-80f6-0fd7f0d68a0f

Device Description

This product is intended to attach a balloon to a FUJIFILM endoscope in medical facilities.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["High-level Disinfectant", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66030	Endoscope balloon positioner, reusable	A hand-held manual device exclusively intended to mount an endoscope balloon or endoscope balloon connector (typically a flexible rubber band) onto the distal end of an endoscope prior to balloon inflation; the balloon and connector are not included. It is available in various designs (e.g., tweezer-, pistol- or cone-like with pointed tip). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24547410432583	GS1	Box	1	In Commercial Distribution
Primary	04547410432589	GS1

Customer Contacts

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

Storage Conditions

• 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: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: There must be no condensation.