FDA.reportPublic FDA data

Impedance/pH, 6 imp channels, 1 pH antimony, Infant, 1.5 cm spacing

Primary DI
08717775953104
Brand
Impedance/pH, 6 imp channels, 1 pH antimony, Infant, 1.5 cm spacing
Company
Medical Measurement Systems B.V.
Model
MMS-Z1-I
Device description
6.4 Fr
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
08717775953104PackageGS15In Commercial Distribution
08717775953098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717775953104087177759531048717775953104
08717775953098087177759530988717775953098

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
08717775954071Impedance/pH, 6 imp channels, 1 pH antimony, LES locatorMMS-Z1-A-LES2016-09-23
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

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