FDA.reportPublic FDA data

Atmo Biosciences

Primary DI
09359921000196
Brand
Atmo Biosciences
Company
ATMO BIOSCIENCES LIMITED
Model
09359921000196
Catalog number
CAP020-0000US
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.
Published
2025-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYVGastrointestinal Motility System, Capsule

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYVGastrointestinal Motility System, CapsuleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250940000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250940000Atmo Gas Capsule SystemAtmo Biosciences, Ltd.2025-06-26NYV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09359921000202PackageGS16In Commercial Distribution
09359921000196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09359921000202093599210002029359921000202
09359921000196093599210001969359921000196

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal telemetric monitoring system capsule, ingestibleA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature14 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1 (612) 429-6279cs@atmobiosciences.com

Regulatory Flags#

DUNS number
745092519
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09359921000073Atmo Biosciences09359921000073REC010-0000US2025-08-05
09359921000004Atmo Biosciences09359921000004CBL010-0000ZZ2025-08-05
09359921000141Atmo Biosciences09359921000073REC010-0000US2025-08-05
09359921000172Atmo Biosciences09359921000172PWR010-0000US2025-08-05
09359921000202Atmo Biosciences09359921000196CAP010-0000US2025-08-05
09359921000318Atmo Biosciences09359921000318MOB010-0000US2025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810164590633MotiliCap GI Monitoring System Data RecorderANX ROBOTICA CORPNYV2026-02-09
00810164590640MotiliCap GI Monitoring System Software (MotiliScan)ANX ROBOTICA CORPNYV2026-02-09
00810164590657MotiliCap GI Monitoring System CapsuleANX ROBOTICA CORPNYV2026-02-09
00810164590817MotiliCap GI Monitoring System Mobile Phone/AppANX ROBOTICA CORPNYV2026-02-09
09359921000073Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000004Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000141Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000172Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000202Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000318Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
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04260167482873SmartPillGiven Imaging, Inc.NYV2017-02-13
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04260167482897SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482903SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167483573SmartPillGiven Imaging, Inc.NYV2017-02-13
07290101367390SmartPillGiven Imaging, Inc.NYV2017-02-13