Sesoronics

GUDID 00851457007278

SENSORONICS INCORPORATED

Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter
Primary Device ID00851457007278
NIH Device Record Keyc9b11318-492e-4e52-8c5d-a4c6086dd66a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSesoronics
Version Model NumberSPO500
Company DUNS079579147
Company NameSENSORONICS INCORPORATED
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851457007278 [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 Date2019-10-07
Device Publish Date2019-09-27

Devices Manufactured by SENSORONICS INCORPORATED

00851457007292 - Sensoronics2019-11-08
00851457007278 - Sesoronics2019-10-07
00851457007278 - Sesoronics2019-10-07
00851457007285 - Sensoronics2019-10-07
00851456007156 - Sensoronics2018-07-06
00851456007163 - Sensoronics2018-07-06
00851456007170 - Sensoronics2018-07-06
00851456007187 - Sensoronics2018-07-06
00851456007194 - Sensoronics2018-07-06

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