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) (10) Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (KLK) (10) Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia (LPP) (10) Oximeter (DQA) (10) Oximeter, Ear (DPZ) (10)

Premarket Exempt

Clear

Multi-Site Attachment Ring for fragile/sensitive skin - 07640121880230 Catalog Number :

Device Description : MAR-SF is intended to attach SenTec TC Sensors to various measurement sites for MAR-SF is intended to attach SenTec TC Sensors to various measurement sites for patients with sensitive, fragile but intact skin.

Device Class :

Duns Number: 480797856

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Standard Starter Set (without Service Gas) - 07640121880308 Catalog Number :

Device Description : Standard Starter Set (without Service Gas) contains:Ear Clips (EC-MI)Multi-Site Standard Starter Set (without Service Gas) contains:Ear Clips (EC-MI)Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)

Device Class : 2

Duns Number: 480797856

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

PSG-X - 07640121880315 Catalog Number :

Device Description : The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Pol The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)

Device Class : 2

Duns Number: 480797856

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Neonatal Starter Set - 07640121880438 Catalog Number :

Device Description : Neonatal Starter Set contains:Multi-Site Attachment Rings for mature/intact skin Neonatal Starter Set contains:Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)Service Gas (GAS-0812)

Device Class : 2

Duns Number: 480797856

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Neonatal Starter Set (without Service Gas) - 07640121880445 Catalog Number :

Device Description : Neonatal Starter Set (without Service Gas) contains:Multi-Site Attachment Rings Neonatal Starter Set (without Service Gas) contains:Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)Service Gas (GAS-0812)

Device Class : 2

Duns Number: 480797856

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Membrane Changer Set - 07640121880490 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-R) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. To enable an economic and cost saving membrane change, the Membrane Changer after use can be reloaded with a new Membrane Changer Insert (MC-I). The memrane changer set contains the MC-R and inserts (MC-I) to reload.Membrane Changer Set [1 membrane changer, 1 insert]

Device Class : 2

Duns Number: 480797856

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Membrane Changer Inserts - 07640121880506 Catalog Number :

Device Description : The Membrane Changer (MC-R) is a reloadable tool to change the membrane of SenTe The Membrane Changer (MC-R) is a reloadable tool to change the membrane of SenTec TC Sensors. Prior reuse, the Membrane Changer (MC-R) must be reloaded with a new Membrane Changer Insert (MC-I). The MC-I is single-use

Device Class :

Duns Number: 480797856

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

V-Sign™ Sensor 2 - 07640121880513 Catalog Number :

Device Description : Digital Sensor for non-invasive and continuous measurement of transcutaneous car Digital Sensor for non-invasive and continuous measurement of transcutaneous carbon dioxide partial pressure and pulse oximetry. Suitable for adult, pediatric and neonatal patients.

Device Class : 2

Duns Number: 480797856

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Staysite Adhesive - 07640121880568 Catalog Number :

Device Description : The Staysite Adhesive (SA-MAR), is an optional, single-use adhesive which is ind The Staysite Adhesive (SA-MAR), is an optional, single-use adhesive which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR-SF if more secure attachment is required.

Device Class :

Duns Number: 480797856

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

PSG Cable A - 07640121880612 Catalog Number :

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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