Standard Starter Set

GUDID 07640121880094

Standard Starter Set contains: Ear Clips (EC-MI) Multi-Site Attachment Rings for mature/intact skin (MAR-MI) Multi-Site Attachment Rings for sensitive

SenTec AG

Pulse Co-oximeter probe, reusable
Primary Device ID07640121880094
NIH Device Record Key3b5fda2e-fc20-4144-afe8-785578a81d32
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandard Starter Set
Version Model NumberSSET
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 Kittrue
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 HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *during transport: 0-50°C
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107640121880094 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-31

Devices Manufactured by SenTec AG

07640121881053 - 103583 LuMon™ Contact Gel Kit2025-09-16
EIT11ST1201000 - 1ST120-100 LuMon™ Connector 2.0 2025-09-16 The LuMon Connector 2.0 is a reusable adapter intended to link a LuMon™ Belt to the LuMon™ Monitor.
EIT11ST2721000 - 1ST272-100 LuMon™ Belt Size 192025-09-16
EIT11ST2731000 - 1ST273-100 LuMon™ Belt Size 222025-09-16
EIT11ST2741000 - 1ST274-100 LuMon™ Belt Size 262025-09-16
EIT11ST2751000 - 1ST275-100 LuMon™ Belt Size 302025-09-16
EIT11ST2761000 - 1ST276-100 LuMon™ Belt Size 352025-09-16
EIT11ST2771000 - 1ST277-100 LuMon™ Belt Size 402025-09-16

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.