SenTec AG

Address:RINGSTRASSE 39,THERWIL Basel-Landschaft,CH

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Monitor, Carbon-Dioxide, Cutaneous (LKD) (7) Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (KLK) (7) Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia (LPP) (7) Oximeter (DQA) (7) Oximeter, Ear (DPZ) (7)

Premarket Exempt

Clear

SDM Water Protection Cover - 07640121880889 Catalog Number :

Device Description : This cover will protect the SenTec Digital Monitor (SDM) from dripping water whe This cover will protect the SenTec Digital Monitor (SDM) from dripping water when the device is tilted up to 15° (IPX2).

Device Class : 2

Duns Number: 480797856

Premarket Exempt : No

Product Code : LPP, LKD, KLK, DQA, DPZ

Prescription Use : Yes

Device Count : 1

Isolation Transformer 100-120V - 07640121880902 Catalog Number :

Device Description : Isolates the SDM from mains for use in home use environments.

Device Class : 2

Duns Number: 480797856

Premarket Exempt : No

Product Code : LPP, LKD, KLK, DQA, DPZ

Prescription Use : Yes

Device Count : 1

Membrane Changer (single-use) / single unit - 07640121880933 Catalog Number :

Device Description : The membrane and the electrolyte of SenTec TC Sensors must be changed periodical The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. The MC is single-use.

Device Class :

Duns Number: 480797856

Premarket Exempt : No

Product Code : DPZ, DQA, KLK, LKD, LPP

Prescription Use : Yes

Device Count : 1

Patient Application Kit with Ear Clip for mature/intact skin - 07640121880957 Catalog Number :

Device Description : A combination of single-use products intended to attach the Sentec sensors to th A combination of single-use products intended to attach the Sentec sensors to the earlobe of the patient, recommended for patients with mature/intact skin.

Device Class :

Duns Number: 480797856

Premarket Exempt : No

Product Code : DPZ, DQA, KLK, LKD, LPP

Prescription Use : Yes

Device Count : 1

Patient Application Kit for mature intact skin - 07640121880964 Catalog Number :

Device Description : A combination of single-use products intended to attach the Sentec sensors to co A combination of single-use products intended to attach the Sentec sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with mature/intact skin

Device Class : 2

Duns Number: 480797856

Premarket Exempt : No

Product Code : KLK, LKD, LPP, DPZ, DQA

Prescription Use : Yes

Device Count : 1

Patient Application Kit for sensitive/fragile skin - 07640121880971 Catalog Number :

Device Description : A combination of single-use products intended to attach the Sentec Sensors to co 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.

Device Class : 2

Duns Number: 480797856

Premarket Exempt : No

Product Code : DPZ, DQA, KLK, LKD, LPP

Prescription Use : Yes

Device Count : 1

Contact Gel - 17640121880862 Catalog Number :

Device Description : The Contact Gel is required for proper CO2 gas conduction from the patient's Ski The Contact Gel is required for proper CO2 gas conduction from the patient's Skin to the SenTec TC Sensors. Every time a SenTec TC Sensors is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor Membrane. GEL-SD is delivered in single dose vials each containing 0.3 g of the solution and is intended for single use.

Device Class : 2

Duns Number: 480797856

Premarket Exempt : No

Product Code : LPP, LKD, KLK, DQA, DPZ

Prescription Use : Yes

Device Count : 1

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