FUJIFILM

Basic Information

• Brand Name: FUJIFILM
• Primary DI: 04547410331370
• Version / Model: BS-2
• Company Name: FUJIFILM CORPORATION
• Labeler DUNS: 713565195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2e44987e-1da7-4ca6-bb86-7cee29f2ee14

Device Description

The balloon is intended to be used in combination with Double Balloon Endoscopes to assist with insertion inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDA	Enteroscope and accessories	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45712	Gastrointestinal/biliary dilation balloon catheter	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, and may be of the fixed-wire or wire-guided type. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04547410331370	GS1
Unit of Use	84547410331376	GS1
Package	14547410331377	GS1	Box	1	In Commercial Distribution

Customer Contacts

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

Storage Conditions

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