Patient Application Kit for sensitive/fragile skin

GUDID 17640121880978

A combination of single-use products intended to attach the Sentec Sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin.

SenTec AG

Transcutaneous blood gas monitoring system
Primary Device ID17640121880978
NIH Device Record Key27e26713-f709-46ff-8be0-92e46bc71524
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient Application Kit for sensitive/fragile skin
Version Model NumberPAK-SF
Company DUNS480797856
Company NameSenTec AG
Device Count1
DM Exemptfalse
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

Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107640121880971 [Primary]
GS117640121880978 [Package]
Contains: 07640121880971
Package: Box [12 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-04
Device Publish Date2021-09-26

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.