AccessGUDID - DEVICE: Atmo Biosciences (09359921000318)

GUDID

Device Identifier (DI) Information

Brand Name: Atmo Biosciences
Version or Model: 09359921000318
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MOB010-0000US
Company Name: ATMO BIOSCIENCES LIMITED

Primary DI Number: 09359921000318
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 745092519 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64248	Panel computer	A non-dedicated, electrically-powered, compact computer unit with an integrated touchscreen monitor designed to be used in a mobile platform (e.g., mounted on a stand, mount, pole, laboratory equipment). It is typically made of or coated with an antimicrobial material to prevent cross-contamination in a medical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NYV	Gastrointestinal Motility System, Capsule

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K250940	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 834f161d-0eed-42c9-8aa7-c0c6e76943c6
Public Version Date: August 13, 2025
Public Version Number: 1
DI Record Publish Date: August 05, 2025