FDA.reportPublic FDA data

pHTip Disposable Catheter

Primary DI
07640172972465
Brand
pHTip Disposable Catheter
Company
Unisensor AG
Model
K6011-EI-0633
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640172972465PackageGS15In Commercial Distribution
07640172972458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640172972465076401729724657640172972465
07640172972458076401729724587640172972458

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-oesophageal pH/impedance catheter, non-sterileA non-sterile flexible tube with electronic sensors at its distal end intended to be inserted through the nose into the oesophagus and stomach to measure pH and/or electrical impedance, typically for the evaluation of gastro-oesophageal reflux disease (GERD), gastric ulcers, or other gastrointestinal conditions. It is made of synthetic polymers and metal materials and is intended to be proximally connected to an appropriate external gastric pH measuring/monitoring device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French

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

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