FDA.reportPublic FDA data

Latitude Catheter

Primary DI
07640172972618
Brand
Latitude Catheter
Company
Unisensor AG
Model
GIM6000E00
Catalog number
K84AC-00-1503
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640172972601PackageGS15In Commercial Distribution
07640172972618PackageGS14In Commercial Distribution
07640172972595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640172972601076401729726017640172972601
07640172972618076401729726187640172972618
07640172972595076401729725957640172972595

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal manometric catheter, non-electronicA non-sterile, non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and anal sphincter functions, typically in the evaluation of GI disorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence]. It functions via infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in/connected to a dedicated analysis system. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(603)570-2675qm@unisensor.ch

Regulatory Flags#

DUNS number
483298907
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
07640172974025UniTip High Resolution CatheterK1036A2-E-22082022-11-03
07640172974032UniTip High Resolution CatheterK121159-00-2209-D2022-11-03
07640172974018UniTip High Resolution CatheterK102059-EL-2106-D2022-04-20
07640172973936UniTip High Resolution CatheterK143659-L6-2103-DK143659-L6-2103-D2022-01-19
07640172973998UniTip High Resolution CatheterK81759-E-2017-D K81759-E-2017-D 2022-01-13
07640172974001UniTip High Resolution CatheterK8159-00-2101-DK8159-00-2101-D2021-10-20
07640172973912UniTip CatheterK6604-00-2011-D2021-02-18
07640172973882UniTip High Resolution CatheterK126A2-00-20142021-02-04
07640172973899UniTip High Resolution CatheterK146A2-00-20152021-02-04
07640172973905UniTip High Resolution CatheterK1212A2-00-20162021-02-04
07640172973851UniTip High Resolution CatheterK1412A2-00-20082020-12-07
07640172973868UniTip CatheterK14172-00-20102020-12-07
07640172973875UniTip CatheterK12172-00-2009 2020-12-07
07640172973844UniTip CatheterK104A2-00-20062020-10-27
07640172973837UniTip High Resolution CatheterK121459-L5-1912-D2020-10-09
07640172973813UniTip High Resolution CatheterK1020A1-EL-1911-D2019-11-11
07640172973783UniTip CatheterK14172-00-19062019-06-17
07640172973790UniTip CatheterK12172-00-19072019-06-17
07640172973806UniTip High Resolution CatheterK143659-00-1910-D2019-06-17
07640172973769UniTip CatheterK8404-00-1903-D2019-05-09

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
10851607003003QuikLinq FOB Adapter MEDSPIRA, LLCKLA2025-03-10
00627825014823SOLAR Anorectal Manometry ChargerLaborie Medical Technologies Corp.KLA2025-03-06
10627825014837SOLAR Anorectal Manometry CatheterLaborie Medical Technologies Corp.KLA2025-03-06
108516070035395-Pack, Luer-Locking, 100cc SyringeMEDSPIRA, LLCKLA2025-03-03
00678467508201Mui ScientificH & A Mui Enterprises IncKLA2025-02-20
B960RED201REDNeuraxis, Inc.KLA2025-01-09
108516070035155-Pack, 100 cc Syringe, Luer-lockingMEDSPIRA, LLCKLA2024-12-20
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
00851607003327Single Patient Kit, mcompass, Anorectal Manometry 5-channelMEDSPIRA, LLCKLA2023-10-06
00851607003334Single Patient Kit, mcompass, Anorectal Manometry 5-channel, PetiteMEDSPIRA, LLCKLA2023-10-06
10851607003348Single Patient Kit, mcompass, Anorectal Manometry 2-channelMEDSPIRA, LLCKLA2023-10-06
10851607003379Medspira Tablet PC with Power SupplyMEDSPIRA, LLCKLA2023-10-06
10851607003393mcompass Anorectal Manometry SystemMEDSPIRA, LLCKLA2023-10-06
00851607003402Catheter, mcompass®, Anorectal Manometry 5-channel, 5-packMEDSPIRA, LLCKLA2023-10-06
10851607003416Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-packMEDSPIRA, LLCKLA2023-10-06
10851607003423Catheter, mcompass®, Biofeedback, 2-channel, 5-packMEDSPIRA, LLCKLA2023-10-06
10851607003430Extension Tube, mcompass® Catheter, 5-packMEDSPIRA, LLCKLA2023-10-06
10851607003447Extension Tube, mcompass® Catheter, 5-packMEDSPIRA, LLCKLA2023-10-06
10851607003454System, mcompass®, Anorectal Manometry MEDSPIRA, LLCKLA2023-10-06
10851607003461System, mcompass®, Anorectal Manometry MEDSPIRA, LLCKLA2023-10-06
10851607003478System, mcompass®, Biofeedback TherapyMEDSPIRA, LLCKLA2023-10-06