DEVICE: Gastrolyzer (05060246860368)

Device Identifier (DI) Information

Gastrolyzer
GastroCHECK
In Commercial Distribution
GASTROCHECK
BEDFONT SCIENTIFIC LIMITED
05060246860368
GS1

1
293959094 *Terms of Use
Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
36320 Ambient gas analyser
An electrically-powered device intended to measure the concentration of one or more gas(es) [e.g., oxygen (O2), carbon dioxide (CO2)] from the ambient environment (e.g., within a room), typically to monitor the work conditions of employees. It is typically a hand-held or wearable sensor unit with controls and display.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
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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

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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

8989ec85-77dd-4c14-a750-33b305b1c64e
September 13, 2024
1
September 05, 2024
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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)

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

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No
Yes
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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