Rad-97

GUDID 00843997014229

with NomoLine Capnography, and camera

MASIMO CORPORATION

Pulse Co-oximeter
Primary Device ID00843997014229
NIH Device Record Key48bb9f07-960a-4a53-95f6-e0fbbaa11dce
Commercial Distribution StatusIn Commercial Distribution
Brand NameRad-97
Version Model Number9802
Company DUNS780421038
Company NameMASIMO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
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 HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 540 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100843997013710 [Direct Marking]
GS100843997014229 [Primary]

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-01
Device Publish Date2019-09-23

On-Brand Devices [Rad-97]

00843997014281Home Use with noninvasive blood pressure, and camera
00843997014229with NomoLine Capnography, and camera
00843997014212with noninvasive blood pressure, and camera
00843997014205with Camera
00843997014199Home Use with camera
00843997013864Rad-97 with NomoLine Capnography
00843997013857Rad-97 with non-invasive blood pressure
00843997012782Rad-97 with NomoLine Capnography
00843997012775Rad-97 with non-invasive blood pressure
00843997012317Rad-97
00843997016612Kit, Rad-97, NIBP, Home Use

Trademark Results [Rad-97]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RAD-97
RAD-97
86758301 5794793 Live/Registered
Masimo Corporation
2015-09-16

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