IDKIT: HP ONE

GUDID 00350402100137

The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to collect the breath sample from the patient.

MERIDIAN BIOSCIENCE ISRAEL LTD

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Primary Device ID	00350402100137
NIH Device Record Key	43e5b6ba-8db6-4313-8b56-2725e5c2b75a
Commercial Distribution Status	In Commercial Distribution
Brand Name	IDKIT: HP ONE
Version Model Number	AC00051
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	true
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter
Height	280 Millimeter
Width	186 Millimeter
Depth	156 Millimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00350402100137 [Primary]
GS1	50350402100132 [Package] Package: Pallet [48 Units] In Commercial Distribution
GS1	60350402100139 [Package] Package: Pallet [96 Units] In Commercial Distribution
GS1	70350402100136 [Package] Package: Box [4 Units] In Commercial Distribution
GS1	80350402100133 [Package] Package: Pallet [216 Units] Discontinued: 2022-11-23 Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173772

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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07290016923162 - BreathID Hp Lab System refurbished	2023-04-19 The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath,
07290016923278 - BreathID Smart System refurbished	2023-04-19 The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, wh
07290016923346 - BreathID Smart System	2023-04-19 The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, wh
07290016923353 - BreathID Smart System	2023-04-19 The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, wh
00350402100137 - IDKIT: HP ONE	2021-12-23The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to collect the breath sample from the patient.
00350402100137 - IDKIT: HP ONE	2021-12-23 The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to collect the breath sample from the patient
20350402100148 - IDKIT: HP TWO	2021-12-23 The IDkit Hp™ Two is a kit for the collection of exhaled breath from a test subject that needs to undergo H. pylori diagnosis
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