8000Q2 Reusable Ear Clip Pulse Oximetry Sensor 114239-001

GUDID 00849686050936

EAR CLIP SENSOR FOR 3150

NONIN MEDICAL, INC.

Pulse oximeter, battery-powered
Primary Device ID00849686050936
NIH Device Record Key2d4a480b-27e0-4c88-ae45-2fe43d77a9b5
Commercial Distribution StatusIn Commercial Distribution
Brand Name8000Q2 Reusable Ear Clip Pulse Oximetry Sensor
Version Model Number8000Q2
Catalog Number114239-001
Company DUNS174959692
Company NameNONIN MEDICAL, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100849686050936 [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 Date2020-11-02
Device Publish Date2020-10-23

Devices Manufactured by NONIN MEDICAL, INC.

00849686052367 - MODEL 3150, WRIST-OX2, BLE2024-11-29 MODEL 3150, WRIST-OX2, BLE
00849686051698 - HANDHELD PULSE OXIMETER2024-09-25 HANDHELD PULSE OXIMETER with 8500, PULSE OXIMETER
00849686065855 - HANDHELD PULSE OXIMETER2024-09-25 HANDHELD PULSE OXIMETER with 2500C, PULSE OXIMETER CHARGER
00849686066524 - Reusable Finger Clip Pulse Oximetry Sensors2024-09-25 Reusable Finger Clip Pulse Oximetry Sensors with 8000AA, FINGER CLIP SENSOR 1M
00849686070637 - RESUSABLE PULSE OXIMETRY SENSOR SYSTEM2024-09-25 RESUSABLE PULSE OXIMETRY SENSOR SYSTEM with 8100Q2, REUSABLE EAR CLIP SENSOR
00849686085976 - REUSABLE PULSE OXIMETRY SOFT SENSORS2024-09-25 REUSABLE PULSE OXIMETRY SOFT SENSORS, 70276 with 8000JFW ADULT FLEXW DISP
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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