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.
IDKIT: HP TWO - AC00063
Device Description
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.
Environmental Conditions
- 25.00
- 20.00
- 25.00
- 20.00
Device Sizes
- Height: 11.4 Centimeter
- Length: 20 Centimeter
- Width: 21 Centimeter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
No Data Available
Device IdentifiersDevice Id: 20350402100148
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00350402100144
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: 00350402100144
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 40350402100142
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00350402100144
Package Quantity: 160
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Pallet
Device Id: 50350402100149
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00350402100144
Package Quantity: 240
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Pallet
Device Id: 90350402100147
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00350402100144
Package Quantity: 400
Package Discontinue Date: 3/19/2023 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Pallet
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