IDKIT: HP TWO

GUDID 20350402100148

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.

MERIDIAN BIOSCIENCE ISRAEL LTD

Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon-13 breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD Carbon isotope breath test kit IVD

Primary Device ID	20350402100148
NIH Device Record Key	4eb1e558-cafc-4dc2-92b7-a3b5b33fcec2
Commercial Distribution Status	In Commercial Distribution
Brand Name	IDKIT: HP TWO
Version Model Number	AC00063
Company DUNS	514832786
Company Name	MERIDIAN BIOSCIENCE ISRAEL LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	true
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter
Height	11.4 Centimeter
Length	20 Centimeter
Width	21 Centimeter

Operating and Storage Conditions

Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00350402100144 [Primary]
GS1	20350402100148 [Package] Contains: 00350402100144 Package: Box [20 Units] In Commercial Distribution
GS1	40350402100142 [Package] Contains: 00350402100144 Package: Pallet [160 Units] In Commercial Distribution
GS1	50350402100149 [Package] Contains: 00350402100144 Package: Pallet [240 Units] In Commercial Distribution
GS1	90350402100147 [Package] Contains: 00350402100144 Package: Pallet [400 Units] Discontinued: 2023-03-19 Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173777

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-12-23
Device Publish Date	2021-12-15

Devices Manufactured by MERIDIAN BIOSCIENCE ISRAEL LTD

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07290016923056 - BreathID Hp System	2021-12-23 The BreathID® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /12CO2 ratio of exhal