FDA.reportPublic FDA data

CIM H4E

Primary DI
08717775955665
Brand
CIM H4E
Company
Medical Measurement Systems B.V.
Model
CIM H4E
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08717775955665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717775955665087177759556658717775955665

GMDN Terms#

Term, Definition table
TermDefinition
Urodynamic measurement systemAn assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry (measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). Long-term recording may also be analysed.

Regulatory Flags#

DUNS number
416277333
Device count
1
Premarket exempt
true
Serial number
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
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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