103149 Calibration Gas

GUDID 07640121880988

The Calibration Gas serves as calibration gas for the Sentec transcutaneous sensors that monitor tcPCO2 and/or tcPO2 (V-Sign™ Sensor 2 and OxiVenT™ Sensor). The Calibration Gas is for use only with the Docking Station integrated in the tCOM+.

SenTec AG

Transcutaneous blood gas monitoring system
Primary Device ID07640121880988
NIH Device Record Keya8d75bcf-9b99-4b7f-bd62-ef26342b471c
Commercial Distribution StatusIn Commercial Distribution
Brand Name103149 Calibration Gas
Version Model Number103149
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 Kitfalse
Device Combination Productfalse
Single Usefalse
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 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even after use.

Device Identifiers

Device Issuing AgencyDevice ID
GS107640121880988 [Primary]

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 Date2024-07-15
Device Publish Date2024-07-05

Devices Manufactured by SenTec AG

07640121880988 - 103149 Calibration Gas2024-07-15The Calibration Gas serves as calibration gas for the Sentec transcutaneous sensors that monitor tcPCO2 and/or tcPO2 (V-Sign™ Sensor 2 and OxiVenT™ Sensor). The Calibration Gas is for use only with the Docking Station integrated in the tCOM+.
07640121880988 - 103149 Calibration Gas2024-07-15 The Calibration Gas serves as calibration gas for the Sentec transcutaneous sensors that monitor tcPCO2 and/or tcPO2 (V-Sign™
07640121880995 - 103164 tCOM+2024-07-15 The Sentec patient monitor, model tCOM+, is a portable stand-alone patient monitor indicated for continuous, non-invasive patien
07640121881008 - 103420 Sensor Adapter Cable (Regular)2024-07-15 The Sensor Adapter Cable is required to connect digital Sentec sensors (V-Sign™ Sensor 2, OxiVenT™ Sensor) to the Sentec tCO
07640121881015 - 103421 Sensor Adapter Cable (Long)2024-07-15 The Sensor Adapter Cable is required to connect digital Sentec sensors (V-Sign™ Sensor 2, OxiVenT™ Sensor) to the Sentec tCO
07640121881022 - 103422 Sensor Adapter Cable (Extra Long)2024-07-15 The Sensor Adapter Cable is required to connect digital Sentec sensors (V-Sign™ Sensor 2, OxiVenT™ Sensor) to the Sentec tCO
17640121881036 - Non-Adhesive Wrap2023-07-31 Sentec’s Non-Adhesive Wrap is intended to be wrapped around the thigh of neonatal patients with very sensitive/fragile skin fo
07640121880957 - Patient Application Kit with Ear Clip for mature/intact skin2021-10-04 A combination of single-use products intended to attach the Sentec sensors to the earlobe of the patient, recommended for patien
17640121880961 - Patient Application Kit for mature intact skin2021-10-04 A combination of single-use products intended to attach the Sentec sensors to conventional measurement sites, recommended for ad
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