AQUARI IMMERSION CONTROLLER REFURB 246AQIR

GUDID 00842430116322

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system Operating table patient pressure distribution monitoring/regulation system

• Primary Device ID: 00842430116322
• NIH Device Record Key: b56ef3b1-f56b-4071-82d0-d195ea689b32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUARI IMMERSION CONTROLLER REFURB
• Version Model Number: 246AQIR
• Catalog Number: 246AQIR
• 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: 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: false

Customer Support Contacts

• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com
• Phone: 800-777-4674
• Email: custserv@mizuhosi.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 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
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 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
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 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
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 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
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 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
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 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
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 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
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 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
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 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
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842430116322 [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: 2024-03-15
• Device Publish Date: 2024-03-07

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

• 00842430116322 - AQUARI IMMERSION CONTROLLER REFURB: 2024-03-15
• 00842430116322 - AQUARI IMMERSION CONTROLLER REFURB: 2024-03-15
• 00842430113727 - FOOT SUPPORT ASSEMBLY: 2024-03-14
• 00842430101212 - Pad Set For GST Tempur-Pedic, 76MM: 2023-09-27
• 00842430101311 - SPAR,LEG,RIGHT RADIOLUCENT,REFURBISHED: 2023-09-27
• 00842430101328 - SPAR, LEG, LEFT, RADIOLUCENT, REFURBISHED: 2023-09-27
• 00842430101335 - SPAR ASSEMBLY, RIGHT, REFURBISHED: 2023-09-27
• 00842430101342 - SPAR ASSEMBLY, LEFT, REFURBISHED: 2023-09-27
• 00842430103414 - UPPER ARM SUPPORT & PAD, REFURBISHED: 2023-09-27