BreathID Hp Lab System refurbished

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience Israel Ltd

Identity

Trade Name: BreathID Hp Lab System refurbished FDA UDI
Generic Name: Infrared spectrometry breath analyser IVD FDA UDI
Device Name: The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 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 Lab 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 Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application FDA UDI
Model / Reference: VS01082R FDA UDI
Description: The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 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 Lab 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 Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application FDA UDI

Identifiers

Primary DI / UDI-DI: 07290016923162 FDA UDI
510(k) Number: K173777 FDA UDI
K220494 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

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Single Use

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Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

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HCT/P

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Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

Yes

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Dimensions & Sizes

Size: Height — 16 Inch FDA UDI
Width — 15 Inch FDA UDI
Depth — 22 Inch FDA UDI
Weight — 15 Kilogram FDA UDI
Height — 10 Inch FDA UDI
Width — 15.7 Inch FDA UDI
Depth — 18 Inch FDA UDI
Weight — 9 Kilogram FDA UDI

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

Cleared under the same submission

K173777 also covers:

K220494 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Meridian Bioscience Israel Ltd

Sources (1)

FDA UDI 38cfe0fa-633c-4228-bbf5-ddc3153f5f35 37 fields · synced May 29, 2026