Identity
- Trade Name
- MT100 Oxygen Sensor Activation System FDA UDI
- Generic Name
- Respiratory oxygen sensor FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MT 100 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- MT 100 FDA UDI
- Primary DI / UDI-DI
- M996MT1000 FDA UDI
- FDA Product Code
- CCL FDA UDI
- GMDN Term
- Respiratory oxygen sensor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1720 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MT100 Oxygen Sensor Activation System by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Industries, Incorporated
Sources (1)
- FDA UDI d4240eb8-b902-4287-9a81-1e307a42dee2 36 fields · synced May 30, 2026