Duns Number:480797856
Device Description: The Contact Gel is required for proper CO2 gas conduction from the patient's Skin to the S 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.
Catalog Number
-
Brand Name
Contact Gel
Version/Model Number
GEL-SD
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151329,K101690,K071672,K041548
Product Code
DPZ
Product Code Name
Oximeter, Ear
Public Device Record Key
52e5368e-b856-406a-bc04-a28618b5c2fe
Public Version Date
March 13, 2019
Public Version Number
1
DI Record Publish Date
March 05, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |