FDA UDI
In Commercial Distribution
🇺🇸 United States
BreathID Hp System
DI: 07290016923148
·
Model: VS01000R
·
MERIDIAN BIOSCIENCE ISRAEL LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BreathID Hp System
- Primary DI
- 07290016923148
- Version / Model
- VS01000R
- Catalog Number
- VS01000R
- Company Name
- MERIDIAN BIOSCIENCE ISRAEL LTD
- Labeler DUNS
- 514832786
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-11
- Public Version
- 2
- Public Version Date
- 2023-06-23
- Public Version Status
- Update
- Public Device Record Key
- 475f7baf-c9e0-46c4-9c69-8e65941412aa
Device Description
The BreathID® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /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® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MSQ | Test, Urea (Breath Or Blood) | Microbiology | 866.3110 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | Clinical Chemistry | 862.2300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016923148 | GS1 |
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 16 | Inch | |
| Width | 15 | Inch | |
| Depth | 22 | Inch | |
| Weight | 15 | Kilogram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 95 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 102 KiloPascal