Rad-97

GUDID 00843997016612

Pulse Co-oximeter

Primary Device ID	00843997016612
NIH Device Record Key	398a738b-22da-4f17-817b-8e4cb5defc69
Commercial Distribution Status	In Commercial Distribution
Brand Name	Rad-97
Version Model Number	95004
Company DUNS	780421038
Company Name	MASIMO CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00843997016612 [Primary]

MWI	Monitor, physiological, patient (without arrhythmia detection or alarms)

Steralize Prior To Use	false
Device Is Sterile	false

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

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