FDA UDI
In Commercial Distribution
🇺🇸 United States
GutTracker
DI: 00860011391500
·
Model: Gen 2
·
G-TECH MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GutTracker
- Primary DI
- 00860011391500
- Version / Model
- Gen 2
- Catalog Number
- 1001
- Company Name
- G-TECH MEDICAL, INC.
- Labeler DUNS
- 053029908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-10
- Public Version
- 1
- Public Version Date
- 2024-06-18
- Public Version Status
- New
- Public Device Record Key
- 848f6d6d-a176-455f-8415-a982ab516475
Device Description
GutTracker measures GI motility of the stomach, small intestine and colon non-invasively over multiple days as patients go about their normal daily lives.The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MYE | System, Electrogastrography (Egg) | Gastroenterology, Urology | 876.1735 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65834 | Wearable multiple vital physiological parameter monitoring system | A portable assembly of electrically-powered devices intended to be worn by a patient in a healthcare or homecare setting for intermittent assessment or continuous monitoring, exclusively by a healthcare professional, of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, haemoglobin oxygen saturation (SpO2), haematocrit]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff, skin patch) and processing hardware with dedicated software. It may include a monitoring screen or allow for remote communication with a smart device or central database. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860011391500 | GS1 | ||||
| Package | 00860011391517 | GS1 | 3 | In Commercial Distribution |
Customer Contacts
- Phone
- 650-282-4776
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212954 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.3 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal