DEVICE: Nellcor (10884521546806)
Device Identifier (DI) Information
Nellcor
MAXNW
In Commercial Distribution
Covidien LP
MAXNW
In Commercial Distribution
Covidien LP
Adult SpO2 Sensor, Low profile connector. For use with Vital Sync Wearable SpO2 Patient Monitor
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
No | |
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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? |
---|---|---|---|---|
31658 | Pulse oximeter probe, single-use |
A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQA | Oximeter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K012891 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 62 and 108 KiloPascal |
Handling Environment Temperature: between 0 and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 50 and 108 KiloPascal |
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Weight, >40, KG; |
Device Record Status
335c42cb-3f12-42da-a973-256f5b41d814
June 24, 2025
11
July 04, 2021
June 24, 2025
11
July 04, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20884521546803 | 24 | 10884521546806 | In Commercial Distribution | CASE |
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