DEVICE: AirLife™ (10190752147287)

Device Identifier (DI) Information

AirLife™
5097PF
In Commercial Distribution
5097PF
AIRLIFE
10190752147287
GS1

1
119058668 *Terms of Use
AirLife™ PFT Filter
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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?
60837 Microbial medical gas filter, single-use
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAH Filter, bacterial, breathing-circuit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K033008 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 55 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

46a493d3-a0ea-418c-bbad-87bd52b067fe
April 17, 2025
4
December 20, 2019
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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
50190752147285 50 10190752147287 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
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(833)327-3284
customersupport@vyaire.com
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