IDKIT: HP ONE

Primary DI
00350402100137
Brand
IDKIT: HP ONE
Company
MERIDIAN BIOSCIENCE ISRAEL LTD
Model
AC00051
Device description
The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to collect the breath sample from the patient.
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
K173772000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173772000BreathID Hp SystemExalenz Bioscience , Ltd.2018-03-08MSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50350402100132PackageGS148In Commercial Distribution
60350402100139PackageGS196In Commercial Distribution
70350402100136PackageGS14In Commercial Distribution
80350402100133PackageGS1216Not in Commercial Distribution
00350402100137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5035040210013250350402100132
6035040210013960350402100139
7035040210013670350402100136
8035040210013380350402100133
00350402100137003504021001373504021001370350402100137

GMDN Terms#

Term, Definition table
TermDefinition
Gas sampling line filter, single-useA screening device intended to be installed in a reusable gas sampling line or gas measuring instrument to remove and retain bacterial pathogens, and sometimes moisture, from the gas. It is designed to prevent a measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, bedside respiration monitor] and the system it is connected to (e.g., a breathing circuit) from becoming contaminated to reduce the risk of patient cross-contamination. Some types function as a water trap to help minimize damage to the measuring instrument from gas condensation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth156Millimeter
Height280Millimeter
Width186Millimeter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514832786
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
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
20350402100148IDKIT: HP TWOAC000632021-12-15