ISA AX + Root

GUDID 00843997012904

ISA AX + Root and Mounting Bracket Kit ISA Sidestream Analyzer and Mounting Bracket for use with Root

MASIMO CORPORATION

Patient monitoring system module rack Patient monitoring system module rack Patient monitoring system module rack Patient monitoring system module rack Patient monitoring system module rack Patient monitoring system module rack Patient monitoring system module rack Patient monitoring system module rack Patient monitoring system module rack Patient monitoring system module rack Patient monitoring system module rack Patient monitoring system module rack Patient monitoring system module rack Patient monitoring system module rack
Primary Device ID00843997012904
NIH Device Record Key0ae78b95-2581-4cad-b25e-fef4e32f94fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameISA AX + Root
Version Model Number4376
Company DUNS780421038
Company NameMASIMO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100843997012904 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-13
Device Publish Date2020-07-03

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00843997017503 - Masimo W12024-03-11 Masimo W1, Global, Switzerland
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