Scope Assist Flushing Sink (SAFS)

GUDID FLUSHINGSINKMODELS8

Device to flush endoscopes

CUSTOM ULTRASONICS, INCORPORATED

Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector

• Primary Device ID: FLUSHINGSINKMODELS8
• NIH Device Record Key: 948a824c-24d0-4d49-9009-b82dd00727a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scope Assist Flushing Sink (SAFS)
• Version Model Number: S8
• Company DUNS: 029526795
• Company Name: CUSTOM ULTRASONICS, INCORPORATED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com
• Phone: 215-364-1477
• Email: info@customultrasonics.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not fork lift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	FLUSHINGSINKMODELS8 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162120

FDA Product Code

• FEB: Accessories, Cleaning, For Endoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-17
• Device Publish Date: 2017-05-16

On-Brand Devices [Scope Assist Flushing Sink (SAFS)]

• FLUSHINGSINKMODELS8: Device to flush endoscopes
• FLUSHINGSINKMODELS6: A device use to flush endoscopes.