IDKIT: HP TWO

Primary DI
00350402100144
Brand
IDKIT: HP TWO
Company
MERIDIAN BIOSCIENCE ISRAEL LTD
Model
AC00063
Device description
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.
Published
2021-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173777000
K193610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173777000BreathID Hp Lab SystemExalenz Bioscience , Ltd.2018-03-08MSQ
K193610000BreathID Smart SystemExalenz Bioscience , Ltd.2020-02-06MSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20350402100148PackageGS120In Commercial Distribution
40350402100142PackageGS1160In Commercial Distribution
50350402100149PackageGS1240In Commercial Distribution
90350402100147PackageGS1400Not in Commercial Distribution
00350402100144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2035040210014820350402100148
4035040210014240350402100142
5035040210014950350402100149
9035040210014790350402100147
00350402100144003504021001443504021001440350402100144

GMDN Terms#

Term, Definition table
TermDefinition
Carbon isotope breath test kit IVDA collection of devices intended to be used for the breath analysis of a carbon isotope (e.g., carbon-13, carbon-14) to investigate suspected gastrointestinal disorders [e.g., gastric emptying disorder (gastroparesis), H. pylori infection]. It consists of an ingestible carbon isotope-labelled substrate and breath specimen containers or collection card. The test relies on the metabolism of the substrate and expiration of carbon isotopes in CO2. It can be administered by a healthcare professional in a clinical setting or alternatively by the patient at home, for subsequent analysis in a clinical laboratory or at the point-of-care. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height11.4Centimeter
Length20Centimeter
Width21Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
514832786
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016923063Auto Sampler (for BreathID Hp Lab System)VS010852024-07-22
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
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