SYSTEM 83 PLUS

GUDID SYSTEM83PLUS2

A device to disinfect endoscopes

CUSTOM ULTRASONICS, INCORPORATED

Endoscope washer/disinfector

• Primary Device ID: SYSTEM83PLUS2
• NIH Device Record Key: 94e3e4b5-88e4-435e-b127-435fe35bd279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYSTEM 83 PLUS
• Version Model Number: SYSTEM 83 PLUS 2
• Company DUNS: 029526795
• Company Name: CUSTOM ULTRASONICS, INCORPORATED
• Device Count: 1
• DM Exempt: false
• 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	B21583PLUS2 [Package]; Package: Corrugated Box [1 Units]; In Commercial Distribution
HIBCC	SYSTEM83PLUS2 [Primary]

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: 2020-04-28
• Device Publish Date: 2016-09-25

Devices Manufactured by CUSTOM ULTRASONICS, INCORPORATED

• SYSTEM83PLUS2 - SYSTEM 83 PLUS: 2020-04-28A device to disinfect endoscopes
• SYSTEM83PLUS2 - SYSTEM 83 PLUS: 2020-04-28 A device to disinfect endoscopes
• FLUSHINGSINKMODELS8 - Scope Assist Flushing Sink (SAFS): 2018-09-17 Device to flush endoscopes
• FLUSHINGSINKMODELS6 - Scope Assist Flushing Sink (SAFS): 2018-07-06 A device use to flush endoscopes.