Identity
- Trade Name
- GutTracker FDA UDI
- Generic Name
- Wearable multiple vital physiological parameter monitoring system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Gen 2 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 1001 FDA UDI
- Primary DI / UDI-DI
- 00860011391500 FDA UDI
- 510(k) Number
- K212954 FDA UDI
- FDA Product Code
- MYE FDA UDI
- GMDN Term
- Wearable multiple vital physiological parameter monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1735 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 3.3 Inch FDA UDI
Category: Wearable multiple vital physiological parameter monitoring system
GutTracker by G-TECH MEDICAL Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wearable multiple vital physiological parameter monitoring system.
- Masimo W1 — MASIMO CORPORATION · Class II
- Spire Health Remote Patient Monitoring System — Convexity Scientific, LLC · Class II
- Radius VSM — MASIMO CORPORATION · Class II
- Masimo W1 — MASIMO CORPORATION · Class II
- Masimo W1 — MASIMO CORPORATION · Class II
- Stork — MASIMO CORPORATION · Class II
- ZOLL Arrhythmia Management System — ZOLL Manufacturing Corporation · Class II
- uCor Heart Failure and Arrhythmia Management System — ZOLL Manufacturing Corporation · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- G-TECH MEDICAL Inc.
Sources (1)
- FDA UDI 848f6d6d-a176-455f-8415-a982ab516475 38 fields · synced May 31, 2026