Atmo Biosciences

Basic Information

• Brand Name: Atmo Biosciences
• Primary DI: 09359921000073
• Version / Model: 09359921000073
• Catalog Number: REC010-0000US
• 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: 1
• Public Version Date: 2025-08-13
• Public Version Status: New
• Public Device Record Key: f30c78e4-5088-42b9-aa94-89e6d9cfcd9b

Device Description

Data Receiver (Receiver): A component of the Atmo Gas Capsule System designed to receive and store information transmitted by the Atmo Gas Capsule.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
62386	Gastrointestinal telemetric monitoring system receiver	A portable, hand-held, electronic component of a gastrointestinal telemetric monitoring system designed to continuously and wirelessly receive electrical signals of gastrointestinal parameters (e.g., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding) from an ingested capsule (not included). It may incorporate a display or be connected to an off-the-shelf device (e.g., computer, printer) to display/print the acquired data; it may also have data recording/storage capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	09359921000141	GS1
Primary	09359921000073	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: Storage Environment Humidity
• Temperature Range: 5 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit