AQUARI SURF BACK SKYTRON 3501B

GUDID 00842430115530

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 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 ID00842430115530
NIH Device Record Keyc6c25efe-dcf1-439a-a160-f51f68aac529
Commercial Distribution StatusIn Commercial Distribution
Brand NameAQUARI SURF BACK SKYTRON 3501B
Version Model Number246-B3502
Company DUNS084527241
Company NameMIZUHO ORTHOPEDIC SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100842430115530 [Primary]

FDA Product Code

FNMMattress, Air Flotation, Alternating Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-13
Device Publish Date2022-05-05

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00842430101342 - SPAR ASSEMBLY, LEFT, REFURBISHED2023-09-27
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