Gastrolyzer
The GastroGENIUS® is a portable desktop monitor which measures hydrogen (H2), methane (CH4) and oxygen (O2) leaves in expired breath samples in response to appropriate substrates. It is…
The GastroGENIUS® is a portable desktop monitor which measures hydrogen (H2), methane (CH4) and oxygen (O2) leaves in expired breath samples in response to appropriate substrates. It is intended to be for multi-patient use on children and adults and used by healthcare professionals primarily in a hospital, or physician’s surgery. The expired breath can be delivered direct to the monitor for immediate analysis via a mouthpiece or a sample can be taken remotely via a breath-bag for subsequent analysis. The GastroGENIUS® will be used by a single patient at a time but will interface with a PC to allow a multi-patient sampling protocol to be performed. The GastroGENIUS® can be used as an aid to diagnose the following disorders: Carbohydrate breakdown deficiency Carbohydrate malabsorption Lactose intolerance Bacterial overgrowth Determination of time of passage through gut Specific diagnosis is not possible with this device; further specific testing would need to be carried out to diagnose a patient’s condition.
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1), Hong Kong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Rayco Electronic Ltd. | Dong Guan | Guangdong | Manufacturer | 2 |
| QI Diagnostics Limited | Mongkok | Hong Kong | Specification developer | 1 |
Record
| Listed by | Bedfont Scientific Ltd., United Kingdom |
|---|---|
| FDA product code | NRH |
| Device type | System, Breath Measurement |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1820 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GastroGENIUS | In distribution | |
| Gastro+ | In distribution | |
| HydroGenius | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BreathTracker | Quintron Instrument Co., Inc. | 2 |
| Tank Support, Safety, Table-Top Plastic | Quintron Instrument Co., Inc. | 1 |
| Sugar, Rx, Lactulose, 10 GM Syrup, USP | Quintron Instrument Co., Inc. | 1 |
| Patient Sample Drying Tube | Quintron Instrument Co., Inc. | 1 |
| AlveoVac Exraction System-USA 24VDC | Quintron Instrument Co., Inc. | 1 |
| Extraction System Output Tubing | Quintron Instrument Co., Inc. | 1 |
| BT Upgrade, CUI, Inc Power Supplies | Quintron Instrument Co., Inc. | 1 |
| SivRite-4 Tubing Assembly | Quintron Instrument Co., Inc. | 1 |
| Stopcock, ONE-WAY, Plastic | Quintron Instrument Co., Inc. | 1 |
| BT GC Loaner SC | Quintron Instrument Co., Inc. | 1 |
| Filter, Foam Plug, 10 Pack | Quintron Instrument Co., Inc. | 1 |
| Loaner Alveovac Extractor | Quintron Instrument Co., Inc. | 1 |
Showing 12 of 22. All products under System, Breath Measurement
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.