IDKIT: HP ONE

Basic Information

• Brand Name: IDKIT: HP ONE
• Primary DI: 00350402100137
• Version / Model: AC00051
• Company Name: MERIDIAN BIOSCIENCE ISRAEL LTD
• Labeler DUNS: 514832786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-15
• Public Version: 2
• Public Version Date: 2022-11-24
• Public Version Status: Update
• Public Device Record Key: 43e5b6ba-8db6-4313-8b56-2725e5c2b75a

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
43987	Gas sampling line filter, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00350402100137	GS1
Package	70350402100136	GS1	Box	4	In Commercial Distribution
Package	50350402100132	GS1	Pallet	48	In Commercial Distribution
Package	60350402100139	GS1	Pallet	96	In Commercial Distribution
Package	80350402100133	GS1	Pallet	216	Not in Commercial Distribution	2022-11-23

Premarket Submissions

Submission Number	Supplement Number
K173772	000

Device Sizes

Type	Value	Unit	Text
Height	280	Millimeter
Width	186	Millimeter
Depth	156	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius