Pre-Processing Sink

GUDID PPS83S8

A device intended to flush endoscopes.

Wassenburg Medical, Inc.

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: PPS83S8
• NIH Device Record Key: d597d277-06fe-44fc-b2cb-b2ca3e4c1e44
• Commercial Distribution Discontinuation: 2018-08-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Pre-Processing Sink
• Version Model Number: 83-S8
• Company DUNS: 118762097
• Company Name: Wassenburg Medical, Inc.
• 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: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com
• Phone: 2153641477
• Email: info@customultrasonics.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Forklift
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• 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 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	PPS83S8 [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: 5
• Public Version Date: 2023-07-03
• Device Publish Date: 2017-10-31

On-Brand Devices [Pre-Processing Sink]

• PPS83S8: A device intended to flush endoscopes.
• PPS83S6: A device intended to flush endoscopes.