Atmo Biosciences

Basic Information

• Brand Name: Atmo Biosciences
• Primary DI: 09359921000196
• Version / Model: 09359921000196
• Catalog Number: CAP020-0000US
• Company Name: ATMO BIOSCIENCES LIMITED
• Labeler DUNS: 745092519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-05
• Public Version: 2
• Public Version Date: 2026-02-17
• Public Version Status: Update
• Public Device Record Key: 403433da-51f5-47a5-b3dd-6efa20258d7a

Device 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.

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: Yes
• Has Lot/Batch Number: No
• 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
NYV	Gastrointestinal Motility System, Capsule	Gastroenterology, Urology	876.1725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62385	Gastrointestinal telemetric monitoring system capsule, ingestible	A battery-powered (conventional or physiologic), electronic component of a gastrointestinal telemetric monitoring system designed to be swallowed by a patient for the wireless signal transmission of one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding). The capsule contains a sensor(s) and the telemetric signals it produces are detected by an extracorporeal (e.g., patient-worn) receiver or transceiver; information is displayed by the receiver, or transmitted by the transceiver to a computer with software for display. The capsule is excreted from the gut. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09359921000202	GS1	Pack of 6	6	In Commercial Distribution
Primary	09359921000196	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K250940	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 5 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 5 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit