DEVICE: Microstream (10884521815346)
Device Identifier (DI) Information
Microstream
PMC40M
In Commercial Distribution
Covidien LP
PMC40M
In Commercial Distribution
Covidien LP
Medtronic Microstream (TM) CO2 NanoPod
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
31339 | Carbon dioxide monitor |
A mains electricity (AC-powered) device intended to continuously measure the concentration of carbon dioxide (CO2) in a gas mixture through a particular method (e.g., electrochemical, infrared absorption, gas chromatographic, mass spectrometric) to determine a patient's ventilatory, circulatory, or metabolic status. It is typically used to measure end-tidal carbon dioxide (EtCO2) in expiratory gases during the administration of anaesthesia or during bedside monitoring. Commonly known as a capnograph or a capnometer, the sampling method can be "mainstream" and/or "sidestream".
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K213518 | 000 |
K213911 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit |
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit |
Handling Environment Atmospheric Pressure: between 100 and 150 Millimeter of Mercury |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 11 and 108 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Electrical rating,5V,0.6A; |
Device Record Status
a6886be5-5493-468f-87ec-5a00f525040e
June 24, 2025
4
June 12, 2023
June 24, 2025
4
June 12, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(508)261-8000
covidien.udi@covidien.com
covidien.udi@covidien.com