AccessGUDID - DEVICE: Atmo Biosciences (09359921000073)

GUDID

Device Identifier (DI) Information

Brand Name: Atmo Biosciences
Version or Model: 09359921000073
Commercial Distribution Status: In Commercial Distribution
Catalog Number: REC010-0000US
Company Name: ATMO BIOSCIENCES LIMITED

Primary DI Number: 09359921000073
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 745092519 *Terms of Use

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

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):	Yes
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?
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.	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
Storage Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 14 and 104 Degrees Fahrenheit
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: f30c78e4-5088-42b9-aa94-89e6d9cfcd9b
Public Version Date: August 13, 2025
Public Version Number: 1
DI Record Publish Date: August 05, 2025