FDA.reportPublic FDA data

Auto Sampler (for BreathID Hp Lab System)

Primary DI
07290016923063
Brand
Auto Sampler (for BreathID Hp Lab System)
Company
MERIDIAN BIOSCIENCE ISRAEL LTD
Model
VS01085
Device 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
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
MSQTest, Urea (Breath Or Blood)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1
MSQTest, Urea (Breath Or Blood)Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173777000
K220494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173777000BreathID Hp Lab SystemExalenz Bioscience , Ltd.2018-03-08MSQ
K220494000BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel , Ltd.2022-06-23MSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016923063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016923063072900169230637290016923063

GMDN Terms#

Term, Definition table
TermDefinition
Infrared spectrometry breath analyser IVDAn electrically-powered laboratory or point-of-care instrument designed to use infrared spectrometry technology for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a specimen of air exhaled from a patient. It is typically used to measure analytes such as ingested carbon isotopes that have been metabolized (e.g., 13C, 14C) to establish a correlation with metabolic profiles or disorders [e.g., gastrointestinal H. pylori infection]. The device operates with minimal technician involvement and complete automation of all procedural steps.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth18Inch
Height10Inch
Weight9Kilogram
Width15.7Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal102 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature59 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514832786
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016923384BreathID Hp Lab DeviceVS020002024-07-22
07290016923391BreathID Hp Lab Device (WIN)VS02000W2024-07-22
07290016923148BreathID Hp SystemVS01000RVS01000R2023-04-11
07290016923162BreathID Hp Lab System refurbishedVS01082R2023-04-11
07290016923278BreathID Smart System refurbishedVS07000R2023-04-11
07290016923353BreathID Smart SystemVS07000WR2023-04-11
00350402100144IDKIT: HP TWOAC000632021-12-15
07290016923346BreathID Smart SystemVS07000W2023-04-11
07290016923056BreathID Hp SystemVS01000VS010002021-12-15
07290016923070BreathID Hp Lab SystemVS010822021-12-15
07290016923223BreathID Smart SystemVS070002021-12-15
00350402100137IDKIT: HP ONE AC000512021-12-15
20350402100148IDKIT: HP TWOAC000632021-12-15

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07290016923391BreathID Hp Lab Device (WIN)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923391BreathID Hp Lab Device (WIN)MERIDIAN BIOSCIENCE ISRAEL LTDMSQ2024-07-22
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