AQUARI SURF BACK SKYTRON 3501B

GUDID 00842430115530

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Operating table patient pressure distribution monitoring/regulation system

• Primary Device ID: 00842430115530
• NIH Device Record Key: c6c25efe-dcf1-439a-a160-f51f68aac529
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUARI SURF BACK SKYTRON 3501B
• Version Model Number: 246-B3502
• Company DUNS: 084527241
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 800-777-4764
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842430115530 [Primary]

FDA Product Code

• FNM: Mattress, Air Flotation, Alternating Pressure

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: 2022-05-13
• Device Publish Date: 2022-05-05

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