Ear Clip easy

GUDID 17640121880817

Single patient use sensor application ear clip, recommended for adult, pediatric and neonatal patients with mature/intact skin

SenTec AG

Pulse Co-oximeter probe, reusable
Primary Device ID17640121880817
NIH Device Record Key358bc304-a8f6-400b-8776-da04fb470d66
Commercial Distribution StatusIn Commercial Distribution
Brand NameEar Clip easy
Version Model NumberECe-MI
Company DUNS480797856
Company NameSenTec AG
Device Count1
DM Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature during transport: 0-50°C
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107640121880810 [Primary]
GS117640121880817 [Package]
Contains: 07640121880810
Package: Box [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-08
Device Publish Date2020-03-31

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