AccessGUDID - DEVICE: Atmo Biosciences (09359921000196)

GUDID

Device Identifier (DI) Information

Brand Name: Atmo Biosciences
Version or Model: 09359921000196
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAP010-0000US
Company Name: ATMO BIOSCIENCES LIMITED

Primary DI Number: 09359921000196
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 745092519 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
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.	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
Handling Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 14 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 14 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 403433da-51f5-47a5-b3dd-6efa20258d7a
Public Version Date: August 13, 2025
Public Version Number: 1
DI Record Publish Date: August 05, 2025