Ear Clip

GUDID 07640121880049

The Ear Clip is required to attach SenTec TC Sensors to the patient’s earlobe. Suitable for patients with earlobes of sufficient size and mature, inta

SenTec AG

Transcutaneous blood gas monitoring system
Primary Device ID07640121880049
NIH Device Record Key248ef429-a348-4daf-88b8-6855a8ffae1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEar Clip
Version Model NumberEC-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

Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107640121880049 [Primary]
GS117640121880046 [Package]
Package: Box [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPZOximeter, Ear

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 Date2016-08-31

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