AQUARI SURF BACK TRUMPF 7000 246-B7000

GUDID 00842430115585

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Operating table patient pressure distribution monitoring/regulation system
Primary Device ID00842430115585
NIH Device Record Keya359d4ae-b08b-43d7-9d29-be142a6db6a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAQUARI SURF BACK TRUMPF 7000
Version Model Number246-B7000
Catalog Number246-B7000
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

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 HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100842430115585 [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 Date2023-01-12
Device Publish Date2023-01-04

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00842430101335 - SPAR ASSEMBLY, RIGHT, REFURBISHED2023-09-27
00842430101342 - SPAR ASSEMBLY, LEFT, REFURBISHED2023-09-27

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