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BreathID Hp System

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience Israel Ltd

Identity

Trade Name
BreathID Hp System FDA UDI
Generic Name
Infrared spectrometry breath analyser IVD FDA UDI
Device Name
The BreathID® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device. FDA UDI
Model / Reference
VS01000R FDA UDI
Description
The BreathID® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device. FDA UDI

Identifiers

Catalog Number
VS01000R FDA UDI
Primary DI / UDI-DI
07290016923148 FDA UDI
510(k) Number
K173772 FDA UDI
K221896 FDA UDI
FDA Product Code
MSQ FDA UDI
JJQ FDA UDI
GMDN Term
Infrared spectrometry breath analyser IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3110 FDA UDI
862.2300 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 16 Inch FDA UDI
Width — 15 Inch FDA UDI
Depth — 22 Inch FDA UDI
Weight — 15 Kilogram FDA UDI

BreathID Hp System by Meridian Bioscience Israel Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K173772 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience Israel Ltd

Sources (1)

  • FDA UDI 475f7baf-c9e0-46c4-9c69-8e65941412aa 38 fields · synced May 30, 2026