FDA.reportPublic FDA data

Atmo Biosciences

Primary DI
09359921000202
Brand
Atmo Biosciences
Company
ATMO BIOSCIENCES LIMITED
Model
09359921000196
Catalog number
CAP010-0000US
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
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
745092519
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09359921000196Atmo Biosciences09359921000196CAP020-0000US2025-08-05
09359921000073Atmo Biosciences09359921000073REC010-0000US2025-08-05
09359921000004Atmo Biosciences09359921000004CBL010-0000ZZ2025-08-05
09359921000141Atmo Biosciences09359921000073REC010-0000US2025-08-05
09359921000172Atmo Biosciences09359921000172PWR010-0000US2025-08-05
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
09359921000196Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000004Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000141Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000172Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000318Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
04260167482682SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482705SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482712SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482873SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482880SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482897SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482903SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167483573SmartPillGiven Imaging, Inc.NYV2017-02-13
07290101367390SmartPillGiven Imaging, Inc.NYV2017-02-13