DEVICE: Omron Air Filters for NE-C28 (00073796328627)

Device Identifier (DI) Information

Omron Air Filters for NE-C28
C28FL
In Commercial Distribution
C28FL
Omron Healthcare, Inc.
00073796328627
GS1

5
054318779 *Terms of Use
Omron Air Filters for Nebulizer NE-C28
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Non-respiratory device ambient air filter A non-sterile filter designed to be installed in a non-respiratory device to clean the ambient air that passes through it to facilitate device operation. It is composed of tightly woven materials which remove particulates/impurities and, depending how it is installed, reduce the concentration of impurities to or from the air. It is typically used in devices that draw in ambient air for use as part of their function (e.g., to cool electrical motors, or to force the air through a mass of sand to liquidize it as in a flotation therapy bed), or devices that, having used the air as a drive gas, exhaust it into a room via the filter. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
CAF Nebulizer (Direct Patient Interface)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K060811 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
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

76ac6541-de15-4749-bb1e-674ec7d50a45
July 06, 2018
3
May 17, 2017
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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
10073796328624 50 00073796328627 In Commercial Distribution Inner Carton
20073796328621 10 10073796328624 In Commercial Distribution Case
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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: 00073796286200 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
1-800-634-4350
ohiquality@omron.com
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