Rad-97

GUDID 00843997016612

Kit, Rad-97, NIBP, Home Use

MASIMO CORPORATION

Pulse Co-oximeter
Primary Device ID00843997016612
NIH Device Record Key398a738b-22da-4f17-817b-8e4cb5defc69
Commercial Distribution StatusIn Commercial Distribution
Brand NameRad-97
Version Model Number95004
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100843997016612 [Primary]

FDA Product Code

MWIMonitor, physiological, patient (without arrhythmia detection or alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-18
Device Publish Date2021-10-08

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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