DEVICE: Omron A.I.R.S. Adult Aerosol Mask (00073796099206)

Device Identifier (DI) Information

Omron A.I.R.S. Adult Aerosol Mask
9920
In Commercial Distribution
9920
Omron Healthcare, Inc.
00073796099206
GS1

1
054318779 *Terms of Use
Omron A.I.R.S. Adult Aerosol Mask
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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
Nebulizing system delivery set, single-use A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
BYG Mask, Oxygen
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 122 Degrees Fahrenheit
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Temperature: between -15 and 50 Degrees Celsius
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
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Clinically Relevant Size

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

b2dc3b15-0b56-41cf-8d7e-1cf8fb5583a8
March 29, 2018
2
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
10073796099203 50 00073796099206 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

[?]
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
No
No
No CLOSE

Customer Contact

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