DEVICE: BAC/VIRAL FILTER MINI + LUER LOCK + ELBOW LOW PROFILE (05055788714637)

Device Identifier (DI) Information

BAC/VIRAL FILTER MINI + LUER LOCK + ELBOW LOW PROFILE
038-42-366U
In Commercial Distribution

FLEXICARE MEDICAL LIMITED
05055788714637
GS1

1
504406273 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Microbial medical gas filter, non-sterile, single-use A non-sterile screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
CAH Filter, Bacterial, Breathing-Circuit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092218 000
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Sterilization

No
No
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

95407135-c9f0-4a9d-b03f-481370799d7a
July 06, 2018
3
October 10, 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
No Package DIs found
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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
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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