FDA.reportPublic FDA data

ManoScan

Primary DI
05704736001328
Brand
ManoScan
Company
Covidien LP
Model
9012P1422
Catalog number
9012P1422
Device description
SUM 8ch radial w/balloon,
Published
2017-05-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLAMONITOR, ESOPHAGEAL MOTILITY, AND TUBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLAMonitor, Esophageal Motility, Anorectal Motility, And TubeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032138000MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETERMedtronic Vascular2003-10-09KLA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05704736001328PrimaryGS10
10884521742826Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05704736001328057047360013285704736001328
1088452174282610884521742826

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521845985INVOSPMC71VP-GE2025-07-03
10884521063150ILA3948L2015-08-28
10884521102422Steel88862345-532015-08-31
10884521103863TaperGuard18780S2016-09-24
10884521211933Shiley5-182372017-05-10
10884521543799SigniaSIGPSHELL2017-08-08
10884521713208EdgeE1455B2016-11-18
10884521713277EdgeE1475X2016-11-18
20884521103631Mallinckrodt5-182372015-08-28
20884521105574Mallinckrodt5-185412015-08-28
40884521105578Shiley5-185412018-05-16
10884521543881SigniaSIGMRET2017-07-24
10884521543874SigniaSIGRIG2017-07-31
10884521620254Shiley862342016-09-24
10884521543812SigniaSIGADAPTXL2017-08-08
10884521101098NellcorMAXPACAI2016-09-24
10884521543782SigniaSIGPHANDLE2017-08-08
10884521543867SigniaSIGSBCHGR2017-08-01
10884521128927SonicisionSCST2016-09-24
10884521543829SigniaSIGADAPTSHORT2017-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00678467508409Mui ScientificH & A Mui Enterprises IncKLA2025-11-17
00678467508225Mui ScientificH & A Mui Enterprises IncKLA2025-04-07
00851607003006QuikLinq FOB Adapter MEDSPIRA, LLCKLA2025-03-10
10851607003003QuikLinq FOB Adapter MEDSPIRA, LLCKLA2025-03-10
00627825014830SOLAR Anorectal Manometry CatheterLaborie Medical Technologies Corp.KLA2025-03-06
00627825014823SOLAR Anorectal Manometry ChargerLaborie Medical Technologies Corp.KLA2025-03-06
10627825014837SOLAR Anorectal Manometry CatheterLaborie Medical Technologies Corp.KLA2025-03-06
008516070035325-Pack, Luer-Locking, 100cc SyringeMEDSPIRA, LLCKLA2025-03-03
108516070035395-Pack, Luer-Locking, 100cc SyringeMEDSPIRA, LLCKLA2025-03-03
00678467508201Mui ScientificH & A Mui Enterprises IncKLA2025-02-20
68051887046715THD Procto Software SystemTHD SPAKLA2025-02-20
B960RED201REDNeuraxis, Inc.KLA2025-01-09
008516070035185-Pack, 100 cc Syringe, Luer-lockingMEDSPIRA, LLCKLA2024-12-20
108516070035155-Pack, 100 cc Syringe, Luer-lockingMEDSPIRA, LLCKLA2024-12-20
00851607003389System Accessory KitMEDSPIRA, LLCKLA2024-11-30
10851607003386System Accessory KitMEDSPIRA, LLCKLA2024-11-30
00851607003525Battery, Tablet PCMEDSPIRA, LLCKLA2024-11-30
00678467508157Mui ScientificH & A Mui Enterprises IncKLA2024-10-11
00678467508140Mui ScientificH & A Mui Enterprises IncKLA2024-07-03
00678467508133Mui ScientificH & A Mui Enterprises IncKLA2024-06-21
00678467508089Mui ScientificH & A Mui Enterprises IncKLA2024-04-16
00678467508096Mui ScientificH & A Mui Enterprises IncKLA2024-04-16
00678467508072Mui ScientificH & A Mui Enterprises IncKLA2024-03-21
68051887043295THD Procto Software SystemTHD SPAKLA2023-12-14
68051887043301THD Procto Software SystemTHD SPAKLA2023-12-14
68051887043318THD Procto Software SystemTHD SPAKLA2023-12-14
68051887043325THD Procto Software SystemTHD SPAKLA2023-12-14
00851607003341Single Patient Kit, mcompass, Anorectal Manometry 2-channelMEDSPIRA, LLCKLA2023-10-06
00851607003372Medspira Tablet PC with Power SupplyMEDSPIRA, LLCKLA2023-10-06
00851607003396mcompass Anorectal Manometry SystemMEDSPIRA, LLCKLA2023-10-06