Reusable Sensors - Soft Pedi

GUDID CST102312592

SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means t

MEDIAID INC

Pulse oximeter, line-powered
Primary Device IDCST102312592
NIH Device Record Key8da9b202-0146-466e-831b-927fb4882269
Commercial Distribution StatusIn Commercial Distribution
Brand NameReusable Sensors - Soft Pedi
Version Model NumberCST102-31259
Company DUNS134990550
Company NameMEDIAID INC
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB425CST102312592 [Primary]
HIBCCCST102312592 [Package]
Contains: B425CST102312592
Package: Box [1 Units]
In Commercial Distribution

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 Date2016-12-08

Devices Manufactured by MEDIAID INC

CST02021212 - Adhesive Disposable SpO2 Sensors with Micro Foam T2018-07-06 SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The senso
CST02021222 - Adhesive Disposable SpO2 Sensors with Micro Foam T2018-07-06 SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The senso
CST02021232 - Adhesive Disposable SpO2 Sensors with Micro Foam T2018-07-06 SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The senso
CST02021242 - Adhesive Disposable SpO2 Sensors with Micro Foam T2018-07-06 SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The senso
CST02022012 - Adhesive Disposable SpO2 Sensors with Micro Foam T2018-07-06 SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The senso
CST02022022 - Adhesive Disposable SpO2 Sensors with Micro Foam T2018-07-06 SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The senso
CST02022032 - Adhesive Disposable SpO2 Sensors with Micro Foam T2018-07-06 SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The senso
CST02022042 - Adhesive Disposable SpO2 Sensors with Micro Foam T2018-07-06 SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The senso

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