DEVICE: Microstream (10884521815346)

Device Identifier (DI) Information

Microstream
PMC40M
In Commercial Distribution

Covidien LP
10884521815346
GS1

1
058614483 *Terms of Use
Medtronic Microstream (TM) CO2 NanoPod
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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".
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K213518 000
K213911 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Electrical rating,5V,0.6A;
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Device Record Status

a6886be5-5493-468f-87ec-5a00f525040e
June 24, 2025
4
June 12, 2023
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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