FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MT100 Oxygen Sensor Activation System
DI: M996MT1000
·
Model: MT 100
·
INSTRUMENTATION INDUSTRIES, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MT100 Oxygen Sensor Activation System
- Primary DI
- M996MT1000
- Version / Model
- MT 100
- Catalog Number
- MT 100
- Company Name
- INSTRUMENTATION INDUSTRIES, INCORPORATED
- Labeler DUNS
- 053146767
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d4240eb8-b902-4287-9a81-1e307a42dee2
- Distribution End Date
- 2016-09-30
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | Anesthesiology | 868.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13538 | Respiratory oxygen sensor | A device designed to detect the presence and determine the concentration of oxygen (O2) by paramagnetic, electrochemical, or other technique. The device is typically used as a component of an oxygen monitor or a patient monitoring device/system that determines the percentage of O2 in medical gases used in an enclosed atmosphere (e.g., an anaesthesia or ventilator circuit, oxygen tent, oxygen therapy device/system tubing) inspired by a patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M996MT1000 | HIBCC |
Customer Contacts
- Phone
- 412-854-1133
- [email protected]