FUJIFILM

Basic Information

• Brand Name: FUJIFILM
• Primary DI: 04547410132786
• Version / Model: SB-602
• Company Name: FUJIFILM CORPORATION
• Labeler DUNS: 713565195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-21
• Public Version: 4
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: 2931f36e-8811-4db9-bd86-8b26b0d6542e

Device Description

This product is a single use suction button for an endoscope. It is used to suck in bodily fluid, etc. through the forceps inlet of an endoscope while attached to the Endoscope under the management of a physician in a medical facility.

Device Characteristics

• Single Use: Yes
• 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: 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
EOQ	BRONCHOSCOPE (FLEXIBLE OR RIGID)	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60759	Endoscopic suction valve, single-use	A device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24547410132780	GS1	Box	20	In Commercial Distribution
Primary	04547410132786	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122535	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 45 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• 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 Humidity
• Temperature Range: 30 – 95 Percent (%) Relative Humidity