WristOx2 Model 3150 with Bluetooth Low Energy

GUDID 00849686051025

Model 3150 WristOx2, BLE Wrist-Worn Pulse Oximeter

NONIN MEDICAL, INC.

Pulse oximetry telemetric monitoring system
Primary Device ID00849686051025
NIH Device Record Key9c61e7bb-4b8e-467f-a08e-eac7578786e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameWristOx2 Model 3150 with Bluetooth Low Energy
Version Model Number3150
Company DUNS174959692
Company NameNONIN MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com
Phone651-380-4305
Emailalex.nelson@nonin.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100849686051025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-04-13
Device Publish Date2021-04-05

Devices Manufactured by NONIN MEDICAL, INC.

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00833166000122 - PALMSAT HANDHELD OXIMETER2024-09-18 PALMSAT HANDHELD OXIMETER WITH 8000SM SENSOR
00833166000139 - PALMSAT HANDHELD OXIMETER2024-09-18 PALMSAT HANDHELD OXIMETER with 8000SM-3
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