FDA.reportPublic FDA data

Flowstar

Primary DI
20814247021223
Brand
Flowstar
Company
Medical Measurement Systems B.V.
Model
U2-1
Published
2024-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EXQCystometer, Electrical Recording

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXQCystometer, Electrical RecordingGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20814247021223PrimaryGS10
00814247021229Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081424702122320814247021223
00814247021229008142470212298142470212290814247021229

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
3
Premarket exempt
true
Serial number
true
Manufacturing 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00890477000395Tri-Electrode Surface EMGSRS Medical Systems, Inc.EXQ2026-03-04
00089047700395Tri-Electrode Surface EMGSRS Medical Systems, Inc.EXQ2026-03-04
00890477000371EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)SRS Medical Systems, Inc.EXQ2026-01-21
00890477000388EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)SRS Medical Systems, Inc.EXQ2026-01-21
00086000980061GleanBright Uro, IncEXQ2025-09-23
00860009800601GleanBright Uro, IncEXQ2025-09-23
00860009800625GleanBright Uro, IncEXQ2025-09-23
00860009800632GleanBright Uro, IncEXQ2025-09-23
00860009800649GleanBright Uro, IncEXQ2025-09-23
00860009800656GleanBright Uro, IncEXQ2025-09-23
08032248487123AtmosDELTA MED SPAEXQ2025-09-02
08032248487147AtmosDELTA MED SPAEXQ2025-09-02
08032248487185Infusion SetDELTA MED SPAEXQ2025-09-02
08032248490130AtmosDELTA MED SPAEXQ2025-09-02
38032248487124AtmosDELTA MED SPAEXQ2025-09-02
08032248487130AtmosDELTA MED SPAEXQ2025-09-02
38032248487148AtmosDELTA MED SPAEXQ2025-09-02
38032248487186Infusion SetDELTA MED SPAEXQ2025-09-02
38032248490131AtmosDELTA MED SPAEXQ2025-09-02
E261MMT11730Infusion SetBIOENGINEERING LABORATORIES SRLEXQ2024-12-09
E261MMT11731Infusion SetBIOENGINEERING LABORATORIES SRLEXQ2024-12-09
E261UDA462150AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-10-10
E261UDA462151AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-10-10
08720648846083Flowsensor3-BTMedical Measurement Systems B.V.EXQ2024-09-17
E261UDA582450AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-03
E261UDAELN0AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-03
E261UDA582451AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-03
E261UDAELN1AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-03
E261UDA362050AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-02
E261UDA362051AtmosBIOENGINEERING LABORATORIES SRLEXQ2024-09-02