AccessGUDID - DEVICE: BreathID Smart System (07290016923223)

GUDID

Device Identifier (DI) Information

Brand Name: BreathID Smart System
Version or Model: VS07000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MERIDIAN BIOSCIENCE ISRAEL LTD

Primary DI Number: 07290016923223
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514832786 *Terms of Use

Device Description: The BreathID® Smart 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® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device.

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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
17474	Infrared spectrometry breath analyser IVD	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSQ	Test, Urea (Breath Or Blood)
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193610	000
K220494	000
K223185	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
Storage Environment Temperature: between 59 and 95 Degrees Fahrenheit
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 102 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Height: 16 Inch
Width: 15 Inch
Depth: 22 Inch
Weight: 15 Kilogram

Device Record Status

Public Device Record Key: ada64117-c04f-4dcd-991d-83fb07a109f1
Public Version Date: July 25, 2023
Public Version Number: 3
DI Record Publish Date: December 15, 2021