DEVICE: IDKIT: HP TWO (00350402100144)

Device Identifier (DI) Information

IDKIT: HP TWO
AC00063
In Commercial Distribution

MERIDIAN BIOSCIENCE ISRAEL LTD
00350402100144
GS1

1
514832786 *Terms of Use
The IDkit Hp™ Two is a kit for the collection of exhaled breath from a test subject that needs to undergo H. pylori diagnosis and that the diagnosis is to be performed by means of the Urea Breath Test (UBT). The exhaled breath is collected into designated breath sample bags. Using the Breath Bags, IDkit: Hp™ Two, enables performing the analysis with the BreathID systems at a different location from the place of breath collection.
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Device Characteristics

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

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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?
61476 Carbon isotope breath test kit IVD
A collection of devices intended to be used for the breath analysis of a carbon isotope (e.g., carbon-13, carbon-14) to investigate suspected gastrointestinal disorders [e.g., gastric emptying disorder (gastroparesis), H. pylori infection]. It consists of an ingestible carbon isotope-labelled substrate and breath specimen containers or collection card. The test relies on the metabolism of the substrate and expiration of carbon isotopes in CO2. It can be administered by a healthcare professional in a clinical setting or alternatively by the patient at home, for subsequent analysis in a clinical laboratory or at the point-of-care. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K173777 000
K193610 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
Handling Environment Temperature: between 20 and 25 Degrees Celsius
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Height: 11.4 Centimeter
Length: 20 Centimeter
Width: 21 Centimeter
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Device Record Status

4eb1e558-cafc-4dc2-92b7-a3b5b33fcec2
June 06, 2024
3
December 15, 2021
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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
20350402100148 20 00350402100144 In Commercial Distribution Box
40350402100142 160 00350402100144 In Commercial Distribution Pallet
50350402100149 240 00350402100144 In Commercial Distribution Pallet
90350402100147 400 00350402100144 2023-03-19 Not in Commercial Distribution Pallet
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
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Customer Contact

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No Customer Contact currently defined
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