FDA.reportPublic FDA data

103164 tCOM+

Primary DI
07640121880995
Brand
103164 tCOM+
Company
SenTec AG
Model
103164
Device description
The Sentec patient monitor, model tCOM+, is a portable stand-alone patient monitor indicated for continuous, non-invasive patient monitoring of carbon dioxide partial pressure (PCO2), oxygen partial pressure (PO2), functional oxygen saturation (SpO2) and pulse rate (PR), using either:• a single, digital sensor (V-Sign™ Sensor 2) for PCO2, SpO2 and PR measurement, OR• a single, digital sensor (OxiVenT™ Sensor) for PCO2, PO2, SpO2 and PR measurementPO2 measurement with tCOM+ is only possible when used in combination with an OxiVenT™ Sensor.
Published
2024-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DPZOximeter, Ear
DQAOximeter
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
LKDMonitor, Carbon-Dioxide, Cutaneous
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPZOximeter, EarCardiovascular2
DQAOximeterCardiovascular2
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas AnesthesiaAnesthesiology2
LKDMonitor, Carbon-Dioxide, CutaneousAnesthesiology2
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232516000Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG2024-05-17LKD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640121880995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640121880995076401218809957640121880995

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous blood gas monitoring systemAn assembly of mains electricity (AC-powered) devices designed for the continuous and transcutaneous measurement of a patient's blood gas parameters, typically blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), haemoglobin oxygen saturation (SpO2), and/or venous blood oxygenation through the jugular vein (SjvO2); often with pulse rate. It consists primarily of a probe for gas detection (e.g., via transcutaneous gas diffusion, or using light spectroscopy) placed on the patient’s skin, and an oximetry monitor for the measurement, analysis, and display of data; patient adhesives and connecting cables may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480797856
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640121880803Multi-Site Attachment Ring for fragile/sensitive skinMARe-SF2019-01-29
07640121880810Ear Clip easyECe-MI2020-03-31
07640121880964Patient Application Kit for mature intact skinPAK-MI2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinPAK-SF2021-09-26
07640121881039Non-Adhesive Wrap1035202023-07-21
07640121880988103149 Calibration Gas1031492024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)1034202024-07-05
07640121881015103421 Sensor Adapter Cable (Long)1034212024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)1034222024-07-05
07640121880957Patient Application Kit with Ear Clip for mature/intact skinPAK-EC2021-09-26
07640121880889SDM Water Protection CoverSDM_WPC2021-08-25
07640121880902Isolation Transformer 100-120VRFT100VA-V12021-05-05
07640121880933Membrane Changer (single-use) / single unitMC2021-02-28
17640121880862Contact GelGEL-SD2019-03-05
07640121880018Sentec Digital MonitorSDM2016-08-31
07640121880032Digital Sensor Adapter Cable, 150 cmAC-1502016-08-31
07640121880049Ear ClipEC-MI2016-08-31
07640121880056Service gasGAS-08122016-08-31
07640121880070Contact GelGEL-042016-08-31
07640121880087Membrane Changer (reloadable) / single unitMC-R2016-08-31

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