Identity
- Trade Name
- Atmo Biosciences FDA UDI
- Generic Name
- Gastrointestinal telemetric monitoring system capsule, ingestible FDA UDI
- Device Name
- Atmo Gas Capsule (Capsule): The ingestible component of the Atmo Gas Capsule System with onboard sensors that measure whole and regional gut transit times. FDA UDI
- Model / Reference
- 09359921000196 FDA UDI
- Description
- Atmo Gas Capsule (Capsule): The ingestible component of the Atmo Gas Capsule System with onboard sensors that measure whole and regional gut transit times. FDA UDI
Identifiers
- Catalog Number
- CAP010-0000US FDA UDI
- Primary DI / UDI-DI
- 09359921000196 FDA UDI
- 510(k) Number
- K250940 FDA UDI
- FDA Product Code
- NYV FDA UDI
- GMDN Term
- Gastrointestinal telemetric monitoring system capsule, ingestible FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Gastrointestinal telemetric monitoring system capsule, ingestible
Atmo Biosciences by Atmo Biosciences, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Atmo Biosciences, Ltd.
Sources (1)
- FDA UDI 403433da-51f5-47a5-b3dd-6efa20258d7a 37 fields · synced May 30, 2026