FDA.reportPublic FDA data

UniTip High Resolution Catheter

Primary DI
07640172973813
Brand
UniTip High Resolution Catheter
Company
Unisensor AG
Model
K1020A1-EL-1911-D
Published
2019-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FFXSystem, Gastrointestinal Motility (Electrical)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFXSystem, Gastrointestinal Motility (Electrical)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062222000UNITIP HIGH RESOLUTION CATHETERUnisensor AG2007-03-15FFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640172973813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640172973813076401729738137640172973813

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal manometric catheter, electronicA non-sterile flexible tube with electronic sensors at the distal end intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract to evaluate peristaltic motility anywhere in the GI tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure; it may additionally be intended to measure pH and electrical impedance and contain a lumen. Also known as a GI solid-state sensor catheter, it is intended for proximal connection to an appropriate gastrointestinal motility analysis system, and the acquired data may be used to generate a 3-D image. This is a reusable device intended to be sterilized/cleaned prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French

Sterilization Methods#

Method table
Method

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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
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
07640172973776UniTip CatheterK8804-00-1823-D2019-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00678467508416Mui ScientificH & A Mui Enterprises IncFFX2026-01-23
00851607003501mcompass Anorectal Balloon Expulsion CatheterMEDSPIRA, LLCFFX2025-12-30
00678467508362Mui ScientificH & A Mui Enterprises IncFFX2025-09-15
00678467508355Mui ScientificH & A Mui Enterprises IncFFX2025-08-28
00678467508348Mui ScientificH & A Mui Enterprises IncFFX2025-08-26
00678467508331Mui ScientificH & A Mui Enterprises IncFFX2025-08-21
10884521855441ManoScanGiven Imaging, Inc.FFX2025-08-21
00678467508300Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
00678467508317Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
00678467508102Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508294Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508270Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00678467508287Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00816734023433Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023440Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023457Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023464Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023471Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023488Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00678467508263Mui ScientificH & A Mui Enterprises IncFFX2025-04-15
00678467508256Mui ScientificH & A Mui Enterprises IncFFX2025-04-15
00678467508232Mui ScientificH & A Mui Enterprises IncFFX2025-04-10
00678467508249Mui ScientificH & A Mui Enterprises IncFFX2025-04-10
00816734023426Zvu®DIVERSATEK HEALTHCARE, INC.FFX2025-03-26
08720648846052SOLAR CompactLaborie Medical Technologies Corp.FFX2025-03-06
28717775956611MPP-PlusMedical Measurement Systems B.V.FFX2025-02-21
00678467508195Mui ScientificH & A Mui Enterprises IncFFX2025-01-31
10884521853317ManoScanGiven Imaging, Inc.FFX2025-01-25
00678467508164Mui ScientificH & A Mui Enterprises IncFFX2024-12-02
10678467508123Mui ScientificH & A Mui Enterprises IncFFX2024-06-17