Contact Gel 2ml
SenTec AG · Model GEL-04 · UDI-DI 07640121880858
4
510(k) clearances
10
Adverse events
1
Recalls
13
Facilities
Description
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 Sensor is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor membrane.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-11-27 | Radiometer America Inc | RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.