Atmo Biosciences REC010-0000US

GUDID 09359921000141

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

ATMO BIOSCIENCES LIMITED

Gastrointestinal telemetric monitoring system receiver

• Primary Device ID: 09359921000141
• NIH Device Record Key: f30c78e4-5088-42b9-aa94-89e6d9cfcd9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atmo Biosciences
• Version Model Number: 09359921000073
• Catalog Number: REC010-0000US
• Company DUNS: 745092519
• Company Name: ATMO BIOSCIENCES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (612) 429-6279
• Email: cs@atmobiosciences.com
• Phone: +1 (612) 429-6279
• Email: cs@atmobiosciences.com
• Phone: +1 (612) 429-6279
• Email: cs@atmobiosciences.com
• Phone: +1 (612) 429-6279
• Email: cs@atmobiosciences.com
• Phone: +1 (612) 429-6279
• Email: cs@atmobiosciences.com
• Phone: +1 (612) 429-6279
• Email: cs@atmobiosciences.com
• Phone: +1 (612) 429-6279
• Email: cs@atmobiosciences.com
• Phone: +1 (612) 429-6279
• Email: cs@atmobiosciences.com
• Phone: +1 (612) 429-6279
• Email: cs@atmobiosciences.com
• Phone: +1 (612) 429-6279
• Email: cs@atmobiosciences.com
• Phone: +1 (612) 429-6279
• Email: cs@atmobiosciences.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	09359921000073 [Primary]
GS1	09359921000141 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250940

FDA Product Code

• NYV: Gastrointestinal Motility System, Capsule

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-13
• Device Publish Date: 2025-08-05

On-Brand Devices [Atmo Biosciences]

• 09359921000318: Mobile Device: A component of the Atmo Gas Capsule System used to initiate a study and upload th
• 09359921000202: Atmo Gas Capsule (Capsule): The ingestible component of the Atmo Gas Capsule System with onboard
• 09359921000172: Power Supply: A component of the Atmo Gas Capsule System used to charge the Receiver and Mobile
• 09359921000141: Data Receiver (Receiver): A component of the Atmo Gas Capsule System designed to receive and sto
• 09359921000004: USB Cable: A component of the Atmo Gas Capsule System that connects the Mobile Device to the Rec