AccessGUDID - DEVICE: IDKIT: HP ONE (00350402100137)

GUDID

Device Identifier (DI) Information

Brand Name: IDKIT: HP ONE
Version or Model: AC00051
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MERIDIAN BIOSCIENCE ISRAEL LTD

Primary DI Number: 00350402100137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514832786 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173772	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 20 and 25 Degrees Celsius
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 280 Millimeter
Width: 186 Millimeter
Depth: 156 Millimeter

Device Record Status

Public Device Record Key: 43e5b6ba-8db6-4313-8b56-2725e5c2b75a
Public Version Date: November 24, 2022
Public Version Number: 2
DI Record Publish Date: December 15, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
70350402100136	4	00350402100137		In Commercial Distribution	Box
50350402100132	48	00350402100137		In Commercial Distribution	Pallet
60350402100139	96	00350402100137		In Commercial Distribution	Pallet
80350402100133	216	00350402100137	2022-11-23	Not in Commercial Distribution	Pallet