Gastrolyzer
Basic Information
- Brand Name
- Gastrolyzer
- Primary DI
- 05060246860399
- Version / Model
- GastroGENIUS
- Catalog Number
- LMTCH4
- Company Name
- BEDFONT SCIENTIFIC LIMITED
- Labeler DUNS
- 293959094
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-15
- Public Version
- 1
- Public Version Date
- 2023-06-23
- Public Version Status
- New
- Public Device Record Key
- cfe77c22-7009-44e6-b6b0-4c58845c33b7
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NRH | System, Breath Measurement | Clinical Chemistry | 862.1820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65452 | Multiple gas breath analyser | An electrically-powered device intended to be used in a clinical setting to simultaneously measure the concentrations of two or more gases [e.g., hydrogen (H2), methane (CH4), oxygen (O2)] in an exhaled breath sample. It typically uses electrochemical analysis to assist with the diagnosis of various conditions (e.g., breakdown deficiency and/or malabsorption of carbohydrates, lactose intolerance). It is typically a desktop sensor unit with controls and display; a breathing mouthpiece and/or an exhaled-gas sample collector may be included with the device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060246860399 | GS1 |