FUJIFILM

Basic Information

• Brand Name: FUJIFILM
• Primary DI: 04547410333312
• Version / Model: EB-530S
• Company Name: FUJIFILM CORPORATION
• Labeler DUNS: 713565195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-14
• Public Version: 4
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: d8c2a0fe-2d52-406a-8ae4-0e7604d76396

Device Description

This device is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree. This device may be used on adults, adolescents and children requiring endoscopic examination and as deemed appropriate by trained medical professionals.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
EOQ	BRONCHOSCOPE (FLEXIBLE OR RIGID)	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17662	Flexible video bronchoscope, reusable	An endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04547410333312	GS1
Package	14547410333319	GS1	Box	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122535	000

Storage Conditions

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