DEVICE: AirLife™ (10889483579282)

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Device Record History
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Device Identifier (DI) Information
AirLife™
2812M-10U
In Commercial Distribution

AIRLIFE
10889483579282
GS1

1
119058668 *Terms of Use
10190752113992
Nasal ETCO2Cannula, Adult 7’O2tube and U/Connect-It™ Adapter with male luer connector and 22 mm (I.D.) x 6 mm (O.D.) adaptor
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
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?
36306 Nasal oxygen cannula, carbon-dioxide-sampling
A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.
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 [?]
K120518 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
f435f638-3ba9-4be9-b092-474f96a6c91a
April 17, 2025
2
February 19, 2025
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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
30889483579286 10 10889483579282 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

[?]
(800)433-2797
info@sun-med.com
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