DEVICE: DUAL NARE NASAL CANNULAE FEMALE LUER CON 10FT O2 TUBE (05055788755432)

Device Identifier (DI) Information

DUAL NARE NASAL CANNULAE FEMALE LUER CON 10FT O2 TUBE
032-10-128U
In Commercial Distribution

FLEXICARE MEDICAL LIMITED
05055788755432
GS1

1
504406273 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35201 Nasal oxygen cannula, basic
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 administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.
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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.
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FDA Product Code

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Product Code Product Code Name
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CAT Cannula, Nasal, Oxygen
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140113 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

36206fc1-ee72-4ae3-911a-0a7c8fdc0215
March 22, 2022
4
October 04, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Yes
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No
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Customer Contact

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No Customer Contact currently defined
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