Scope Assist Flushing Sink (SAFS)

GUDID G434FLUSHINGSINKMODELS8

Device to flush endoscopes

Wassenburg Medical, Inc.

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• Primary Device ID: G434FLUSHINGSINKMODELS8
• NIH Device Record Key: 51779bf7-b1d8-49fd-b622-241607a07c3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scope Assist Flushing Sink (SAFS)
• Version Model Number: 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: 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
• 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 *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	G434FLUSHINGSINKMODELS8 [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: 2023-08-21
• Device Publish Date: 2023-08-11

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