Identity
- Trade Name
- Gastrolyzer FDA UDI
- Generic Name
- Ambient gas analyser FDA UDI
- Device Name
- Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath. FDA UDI
- Model / Reference
- GastroCHECK FDA UDI
- Description
- Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath. FDA UDI
Identifiers
- Catalog Number
- GASTROCEHCK-US FDA UDI
- Primary DI / UDI-DI
- 05060246860375 FDA UDI
- FDA Product Code
- LXG FDA UDI
- GMDN Term
- Ambient gas analyser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ambient gas analyser
Gastrolyzer by Bedfont Scientific Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bedfont Scientific Limited
Sources (1)
- FDA UDI 150eb625-d977-452e-b2e0-b4392fab0f77 34 fields · synced May 30, 2026