IDKIT: HP TWO

Basic Information

• Brand Name: IDKIT: HP TWO
• Primary DI: 00350402100144
• Version / Model: AC00063
• Company Name: MERIDIAN BIOSCIENCE ISRAEL LTD
• Labeler DUNS: 514832786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-15
• Public Version: 2
• Public Version Date: 2023-03-20
• Public Version Status: Update
• Public Device Record Key: 4eb1e558-cafc-4dc2-92b7-a3b5b33fcec2

Device Description

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
61476	Carbon-13 breath test kit IVD	A collection of devices intended to be used for carbon-13 breath analysis to investigate suspected gastrointestinal disorders [e.g., gastric emptying disorder (gastroparesis), H. pylori infection]. It consists of an ingestible carbon-13 labelled substrate and breath specimen containers. The test relies on the metabolism of the substrate and expiration of carbon-13 isotopes in CO2. It can be administered by a healthcare professional in a clinical setting and alternatively by the patient at home; the collected expired breath sample is analysed by an infrared or mass spectrometry analyser (not included) in a clinical laboratory or at the point-of-care. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20350402100148	GS1	Box	20	In Commercial Distribution
Primary	00350402100144	GS1
Package	40350402100142	GS1	Pallet	160	In Commercial Distribution
Package	50350402100149	GS1	Pallet	240	In Commercial Distribution
Package	90350402100147	GS1	Pallet	400	Not in Commercial Distribution	2023-03-19

Premarket Submissions

Submission Number	Supplement Number
K173777	000
K193610	000

Device Sizes

Type	Value	Unit	Text
Height	11.4	Centimeter
Length	20	Centimeter
Width	21	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius