Atmo Biosciences MOB010-0000US

GUDID 09359921000318

Mobile Device: A component of the Atmo Gas Capsule System used to initiate a study and upload the results via the Clinic App.

ATMO BIOSCIENCES LIMITED

Panel computer
Primary Device ID09359921000318
NIH Device Record Key834f161d-0eed-42c9-8aa7-c0c6e76943c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtmo Biosciences
Version Model Number09359921000318
Catalog NumberMOB010-0000US
Company DUNS745092519
Company NameATMO BIOSCIENCES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (612) 429-6279
Emailcs@atmobiosciences.com
Phone+1 (612) 429-6279
Emailcs@atmobiosciences.com
Phone+1 (612) 429-6279
Emailcs@atmobiosciences.com
Phone+1 (612) 429-6279
Emailcs@atmobiosciences.com
Phone+1 (612) 429-6279
Emailcs@atmobiosciences.com
Phone+1 (612) 429-6279
Emailcs@atmobiosciences.com
Phone+1 (612) 429-6279
Emailcs@atmobiosciences.com
Phone+1 (612) 429-6279
Emailcs@atmobiosciences.com
Phone+1 (612) 429-6279
Emailcs@atmobiosciences.com
Phone+1 (612) 429-6279
Emailcs@atmobiosciences.com
Phone+1 (612) 429-6279
Emailcs@atmobiosciences.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109359921000318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NYVGastrointestinal Motility System, Capsule

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-13
Device Publish Date2025-08-05

On-Brand Devices [Atmo Biosciences]

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

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