DEVICE: IDKIT: HP TWO (00350402100144)
Device Identifier (DI) Information
IDKIT: HP TWO
AC00063
In Commercial Distribution
MERIDIAN BIOSCIENCE ISRAEL LTD
AC00063
In Commercial Distribution
MERIDIAN BIOSCIENCE ISRAEL LTD
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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
[?]Product Code | Product Code Name |
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No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K173777 | 000 |
K193610 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 20 and 25 Degrees Celsius |
Storage Environment Temperature: between 20 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Height: 11.4 Centimeter |
Length: 20 Centimeter |
Width: 21 Centimeter |
Device Record Status
4eb1e558-cafc-4dc2-92b7-a3b5b33fcec2
June 06, 2024
3
December 15, 2021
June 06, 2024
3
December 15, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined