SpO2 Sensor

GUDID 06944413805378

Edan Instruments, Inc.

Pulse oximeter probe, reusable
Primary Device ID06944413805378
NIH Device Record Key329a2937-a432-4e31-b24b-3dcbf278c33d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpO2 Sensor
Version Model NumberSpO2 Silicone Soft-tip Sensor,pediatric,1m,reusabl
Company DUNS529173163
Company NameEdan Instruments, 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413805378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

On-Brand Devices [SpO2 Sensor]

06944413807129SH6, Ear Clip, Adult/Pediatric, 1m, reusable
06944413805439SHD-A , adult, disposable
06944413805422SHD-P, pediatric, disposable
06944413805415SHD-I , Infant, disposable
06944413805408SHD-N, Neonate, disposable
06944413805385SH5 pediatric Silicone Soft-tip
06944413805378SpO2 Silicone Soft-tip Sensor,pediatric,1m,reusabl
06944413805361SH4 Adult Silicone Soft-tip
06944413805354SpO2 Silicone Soft-tip Sensor,adult,1m, reusable
06944413805347SpO2 Sensor, Wrap, Neonate, 1m, reusable
06944413805323SpO2 Finger Sensor, adult, 1m, reusable
06944413805309SpO2 Finger Sensor, adult, 2.5m, reusable
06944413810846SH1
0694441381205502.57.225039

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