Duns Number:053146767
Device Description: The MT 100 Oxygen Sensor Activation System is designed for use with the Maxtec Handi Oxyge The MT 100 Oxygen Sensor Activation System is designed for use with the Maxtec Handi Oxygen Analyzer. By utilizing a check valve in the Tee Adapter, an airtight seal is maintained in-line, unless actuated by the stem of the activator. This system therefore provides the capability of rapid monitoring of the patient breathing environment without the inconvenience of breaking the ventilation circuit.
Catalog Number
MT 100
Brand Name
MT100 Oxygen Sensor Activation System
Version/Model Number
MT 100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2016
Issuing Agency
In HIBCC
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"
Yes
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
-
Product Code
CCL
Product Code Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Public Device Record Key
d4240eb8-b902-4287-9a81-1e307a42dee2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |