DEVICE: Contact Gel (07640121880070)

Device Identifier (DI) Information

Contact Gel
GEL-04
In Commercial Distribution

SenTec AG
07640121880070
GS1

1
480797856 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46934 Transcutaneous blood gas monitoring system
An 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.
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37178 Transcutaneous blood gas monitor sensor
A device intended to be used with a transcutaneous blood gas monitor to measure a patient's blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), and/or blood oxygen saturation transcutaneously (through the skin). Gases diffuse through the skin and into this sensor at the skin surface, where it transmits electrical signals to the parent device for analysis. This is a reusable device.
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47582 Pulse Co-oximeter probe, reusable
A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection. Signals from the probe, produced by a light-emitting diode (LED) and a receiving detector, are used to calculate results which are digitally displayed on the Co-oximeter's computerized unit. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
DPZ Oximeter, Ear
DQA Oximeter
KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
LKD Monitor, Carbon-Dioxide, Cutaneous
LPP Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K041548 000
K071672 000
K101690 000
K151329 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Total Volume: 5 Milliliter
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Device Record Status

e5a98c9b-b8b8-420c-bee8-c0d69c895e28
July 06, 2018
3
August 31, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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No
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Customer Contact

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No Customer Contact currently defined
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