DEVICE: Vivatmo pro Level 0 (04059233000307)

Device Identifier (DI) Information

Vivatmo pro Level 0
F09G100230
In Commercial Distribution
F09G100230
Bosch Healthcare Solutions GmbH
04059233000307
GS1

5
341189007 *Terms of Use
Disposable mouthpiece for Vivatmo
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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?
65819 Electrochemical breath analyser filter/mouthpiece IVD
A device designed as a breathing mouthpiece and filter intended to be attached to an in vitro diagnostic electrochemical breath analyser to facilitate exhaled air specimen sampling and accurate measurement of target chemical and/or biological markers. It has an integrated reactive filtering material to remove potentially confounding species (e.g., ammonia, methanol) and to chemically prepare the specimen for measurement [e.g., via oxidation]; it may also be designed to remove target particles to provide a control baseline measurement. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MXA System, Test, Breath Nitric Oxide
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Handling Environment Humidity: between 15 and 60 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry
Handling Environment Atmospheric Pressure: between 78 and 110 KiloPascal
Handling Environment Temperature: between 15 and 27 Degrees Celsius
Storage Environment Temperature: between 5 and 40 Degrees Celsius
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Clinically Relevant Size

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

a90df9b6-610d-4f17-bf6c-aef0237c70ad
July 16, 2024
1
July 08, 2024
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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
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: 04059233000277 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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