DEVICE: Nellcor (10884521546806)

Device Identifier (DI) Information

Nellcor
MAXNW
In Commercial Distribution

Covidien LP
10884521546806
GS1

1
058614483 *Terms of Use
Adult SpO2 Sensor, Low profile connector. For use with Vital Sync Wearable SpO2 Patient Monitor
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DQA Oximeter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K012891 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
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
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Weight, >40, KG;
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Device Record Status

335c42cb-3f12-42da-a973-256f5b41d814
June 24, 2025
11
July 04, 2021
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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
20884521546803 24 10884521546806 In Commercial Distribution CASE
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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