FDA.reportPublic FDA data

Atmo Biosciences

Primary DI
09359921000004
Brand
Atmo Biosciences
Company
ATMO BIOSCIENCES LIMITED
Model
09359921000004
Catalog number
CBL010-0000ZZ
Device description
USB Cable: A component of the Atmo Gas Capsule System that connects the Mobile Device to the Receiver and to the Power Supply.
Published
2025-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
09359921000004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09359921000004093599210000049359921000004

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
745092519
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09359921000196Atmo Biosciences09359921000196CAP020-0000US2025-08-05
09359921000073Atmo Biosciences09359921000073REC010-0000US2025-08-05
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
09359921000196Atmo 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
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