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Atmo Biosciences

FDA UDI

Class II (US FDA UDI)

by Atmo Biosciences, Ltd.

Identity

Trade Name
Atmo Biosciences FDA UDI
Generic Name
Gastrointestinal telemetric monitoring system receiver FDA UDI
Device Name
Data Receiver (Receiver): A component of the Atmo Gas Capsule System designed to receive and store information transmitted by the Atmo Gas Capsule. FDA UDI
Model / Reference
09359921000073 FDA UDI
Description
Data Receiver (Receiver): A component of the Atmo Gas Capsule System designed to receive and store information transmitted by the Atmo Gas Capsule. FDA UDI

Identifiers

Catalog Number
REC010-0000US FDA UDI
Primary DI / UDI-DI
09359921000073 FDA UDI
510(k) Number
K250940 FDA UDI
FDA Product Code
NYV FDA UDI
GMDN Term
Gastrointestinal telemetric monitoring system receiver 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gastrointestinal telemetric monitoring system receiver

Atmo Biosciences by Atmo Biosciences, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal telemetric monitoring system receiver.

Cleared under the same submission

K250940 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atmo Biosciences, Ltd.

Sources (1)

  • FDA UDI f30c78e4-5088-42b9-aa94-89e6d9cfcd9b 37 fields · synced May 30, 2026