FDA.reportPublic FDA data

ManoView

Primary DI
07290101369578
Brand
ManoView
Company
Given Imaging, Inc.
Model
FGS-0628
Device description
ManoView (TM) ESO Software Analysis Program
Published
2019-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
NEZSYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFXSystem, Gastrointestinal Motility (Electrical)Gastroenterology, Urology2
NEZSystem, Imaging, Gastrointestinal, Wireless, CapsuleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151086000ManoScan SystemGiven Imaging , Ltd.2016-04-28FFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290101369578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290101369578072901013695787290101369578

GMDN Terms#

Term, Definition table
TermDefinition
Manometric gastrointestinal motility analysis systemAn assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
090073722
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521845916PillCamFGS-08022024-11-14
10884521845923PillCamFGS-08032024-11-14
10884521836181PillCamFGS-07072023-10-05
07290110360795PillCamFGS-06652021-10-16
07290110361167PillCamFGS-06742021-01-31
07290101369530PillCamFGS-06262019-08-11
07290101362128RAPIDFGS-04102016-09-24
07290101362234RAPIDFGS-03992016-09-24
07290101362265RAPIDFGS-03962016-09-24
07290101362784RAPIDFGS-04342016-09-24
07290101363477RAPIDFGS-04722016-09-24
07290101364184RAPIDFGS-04852016-09-24
07290101364207RAPIDFGS-04872016-09-24
07290101364856RAPIDFGS-05232016-09-24
07290101364863RAPIDFGS-05242016-09-24
07290101364870RAPIDFGS-05252016-09-24
07290101364993RAPIDFGS-0478-012016-09-24
07290101365006RAPIDFGS-0479-012016-09-24
07290101365013RAPIDFGS-0480-012016-09-24
07290101365266RAPIDFGS-05402016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10678467508437Mui ScientificH & A Mui Enterprises IncFFX2026-04-15
00810164590114NaviCam Data RecorderANX ROBOTICA CORPNEZ2026-02-16
00810164590145NaviCam LocatorANX ROBOTICA CORPNEZ2026-02-16
00810164590169NaviCam ESView SoftwareANX ROBOTICA CORPNEZ2026-02-16
00810164590794NaviCam ESView 3.XANX ROBOTICA CORPNEZ2026-02-16
00810164590008NaviCam SB CapsuleANX ROBOTICA CORPNEZ2026-02-09
00810164590039NaviCam SB Capsule/TetherANX ROBOTICA CORPNEZ2026-02-09
00810164590718NaviCam XS CapsuleANX ROBOTICA CORPNEZ2026-02-09
00810164590732NaviCam XS Capsule/TetherANX ROBOTICA CORPNEZ2026-02-09
10678467508413Mui ScientificH & A Mui Enterprises IncFFX2026-01-23
00678467508416Mui ScientificH & A Mui Enterprises IncFFX2026-01-23
00867770000278CE Deliver CAPSOVISION, INC.NEZ2026-01-08
00867770000285CE Deliver CAPSOVISION, INC.NEZ2026-01-08
00678467508393Mui ScientificH & A Mui Enterprises IncFFX2025-11-04
00678467508386Mui ScientificH & A Mui Enterprises IncFFX2025-10-21
10678467508352Mui ScientificH & A Mui Enterprises IncFFX2025-08-28
10678467508345Mui ScientificH & A Mui Enterprises IncFFX2025-08-26
10678467508338Mui ScientificH & A Mui Enterprises IncFFX2025-08-21
10678467508307Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
10678467508314Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
10678467508109Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
10678467508291Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
10678467508253Mui ScientificH & A Mui Enterprises IncFFX2025-04-15
10678467508239Mui ScientificH & A Mui Enterprises IncFFX2025-04-10
10678467508246Mui ScientificH & A Mui Enterprises IncFFX2025-04-10
18717775956614MPP-PlusMedical Measurement Systems B.V.FFX2025-02-21
B960RED201REDNeuraxis, Inc.FFX2025-01-09
10884521845848PillCam GeniusGiven Imaging, Inc.NEZ2024-11-29
10884521845916PillCamGiven Imaging, Inc.NEZ2024-11-14
10884521845923PillCamGiven Imaging, Inc.NEZ2024-11-14