FDA.reportPublic FDA data

SmartPill

Primary DI
04260167482682
Brand
SmartPill
Company
Given Imaging, Inc.
Model
FGS-0503
Device description
capsule, 5-pack
Published
2017-02-13
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
K092342000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092342000SMARTPILL GI MONITORING SYSTEM, VERSION 2.0The Smartpill Corporation2009-10-30NYV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260167482682PrimaryGS10
10884521726147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260167482682042601674826824260167482682
1088452172614710884521726147

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal telemetric monitoring systemAn assembly of devices designed to continuously measure and transmit signals for one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding) from a patient to a receiving location for viewing. It consists of a battery-powered capsule swallowed by the patient, and a patient-worn or clinician-held unit designed to wirelessly receive data from the capsule to either transmit it (i.e., a transceiver) to a computing device or to display it (e.g., a receiver); various solutions/containers may also be included. It is intended to help diagnose gastric pH disorders and/or measure gastrointestinal transit times to evaluate motility disorders.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00;
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
090073722
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290101365921ManoScanFGS-05712017-07-20
07290101369578ManoViewFGS-06282019-08-11
10884521855441ManoScanFGS-07152025-08-21
07290101364221PillCamRFB-03472017-02-02
04260167480954ManoScan38852016-09-24
04260167480961ManoScan38872016-09-24
04260167482446ManoScan38902016-09-24
04260167482460ManoScan21952016-09-24
04260167482477ManoScan21922016-09-24
04260167482484ManoScan12862016-09-24
07290101365686PillCamRFB-01542016-09-24
10884521853317ManoScanFGS-80382025-01-25
10884521846975PillCam GeniusFGS-08062024-11-29
10884521845848PillCam GeniusFGS-06892024-11-29
20884521845845PillCam GeniusFGS-06892024-11-29
10884521845831PillCam GeniusFGS-06882024-11-14
10884521845916PillCamFGS-08022024-11-14
10884521845923PillCamFGS-08032024-11-14
10884521836181PillCamFGS-07072023-10-05
07290101364474PillcamRFB-03552017-02-02

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
09359921000202Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000318Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
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