FDA.reportPublic FDA data

Impedance/pH, 6 imp channels, 1 pH antimony, LES locator

Primary DI
08717775954071
Brand
Impedance/pH, 6 imp channels, 1 pH antimony, LES locator
Company
Medical Measurement Systems B.V.
Model
MMS-Z1-A-LES
Device description
Adult, 6.9 Fr
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K012232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012232000INSIGHT, MODEL S980000Sandhill Scientific, Inc.2002-06-07FFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717775954088PackageGS15In Commercial Distribution
08717775954071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717775954088087177759540888717775954088
08717775954071087177759540718717775954071

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal motility analysis systemAn assembly of devices designed to evaluate peristaltic motility in the oesophagus by measuring pressure on an intraluminal catheter/probe at several points (including LES); it also measures pH, respiration, and swallowing with appropriate sensors. In addition to a monitor display, computer, and software, it usually includes nonperfusion catheters to measure pressures directly and/or perfusion catheters and extracorporeal transducers to measure pressure indirectly. The system is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), and/or noncardiac chest pain; it is also used to assess connective tissue and neuromuscular disease.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
416277333
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717775955009Solar GI HRAM H2O, 24p, Trolley systemG3-142016-09-23
08717775955023Solar GI LGI H20, Compact Pole systemG3-32016-09-23
08717775955030Solar GI UGI H20, Trolley systemG3-52016-09-23
08717775955047Solar GI LGI H20, Trolley systemG3-62016-09-23
08717775955054Solar GI HRM H20, 24p, Compact Pole systemG3-72016-09-23
08717775955061Solar GI HRM H20, 24p, Trolley systemG3-82016-09-23
08717775955078Solar GI HRM H2O, 36p, Trolley systemG3-122016-09-23
08717775955085Solar GI HRAM H2O, 24p, Trolley systemG3-142016-09-23
08717775955092Solar GI HRM Solid State, Trolley systemG3-92016-09-23
08717775955108Solar GI HRIM Solid State, Trolley systemG3-102016-09-23
08717775955115Solar GI HRAM Solid State, Trolley systemG3-152016-09-23
08720648846007Solar GI air-charged 4P, Compact Pole systemG3-7 Air2022-05-07
08717775953050Impedance/pH, 6 imp channels, 1 pH antimony, Pediatric, 6.4 FrMMS-Z1-P-7R2016-09-23
08717775953098Impedance/pH, 6 imp channels, 1 pH antimony, Infant, 1.5 cm spacingMMS-Z1-I2016-09-23
08717775953012Impedance/pH, 6 imp channels, 1 pH antimony, Adult, 6.4 FrMMS-Z1-A2016-09-23
08717775953036Impedance/pH, 6 imp channels, 2 pH antimony, Gastric+oes pH, AdultMMS-Z2G-A2016-09-23
08717775954095Impedance/pH,6 imp channels,2 pH antimony,acid LPR + oes,LES locatorMMS-Z2L-A-LES2016-09-23
08717775955016Ohmega RG2-12016-09-23
18717775956614MPP-PlusMPP-MT2025-02-21
28717775956611MPP-PlusMPP-MT2025-02-21

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