Duns Number:480797856
Device Description: The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For th 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).
Catalog Number
-
Brand Name
Membrane Changer (reloadable) / single unit
Version/Model Number
MC-R
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
-
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
K071672,K101690,K151329,K041548,K151329,K101690,K071672,K041548,K041548,K071672,K101690,K151329
Product Code
DPZ
Product Code Name
Oximeter, Ear
Public Device Record Key
c98cd8b8-6871-4543-b151-30e82cf4857c
Public Version Date
November 07, 2019
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
17640121880084
Quantity per Package
9
Contains DI Package
07640121880087
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |