Scope Assist Flushing Sink (SAFS)

GUDID 00860010835210

A device use to flush endoscopes.

Wassenburg Medical, Inc.

Endoscope washer-disinfector (chemical)

• Primary Device ID: 00860010835210
• NIH Device Record Key: 80e7cbf5-a5c3-479e-9285-80399e80fe54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scope Assist Flushing Sink (SAFS)
• Version Model Number: S6
• Company DUNS: 118762097
• Company Name: Wassenburg Medical, Inc.
• 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@wassenburgmedical.com
• Phone: 215-364-1477
• Email: info@wassenburgmedical.com
• Phone: 215-364-1477
• Email: info@wassenburgmedical.com
• Phone: 215-364-1477
• Email: info@wassenburgmedical.com
• Phone: 215-364-1477
• Email: info@wassenburgmedical.com
• Phone: 215-364-1477
• Email: info@wassenburgmedical.com
• Phone: 215-364-1477
• Email: info@wassenburgmedical.com
• Phone: 215-364-1477
• Email: info@wassenburgmedical.com
• Phone: 215-364-1477
• Email: info@wassenburgmedical.com
• Phone: 215-364-1477
• Email: info@wassenburgmedical.com
• Phone: 215-364-1477
• Email: info@wassenburgmedical.com

Operating and Storage Conditions

• 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 *Fraglie
• 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 *Fraglie
• 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 *Fraglie
• 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 *Fraglie
• 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 *Fraglie
• 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 *Fraglie
• 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 *Fraglie
• 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 *Fraglie
• 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 *Fraglie
• 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 *Fraglie
• 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 *Fraglie

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010835210 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-01
• Device Publish Date: 2024-04-23

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

• G434FLUSHINGSINKMODELS8: Device to flush endoscopes
• G434FLUSHINGSINKMODELS6: A device use to flush endoscopes.
• 00860010835227: Device to flush endoscopes
• 00860010835210: A device use to flush endoscopes.