FDA.reportPublic FDA data

Infusion Set

Primary DI
E261MMT11730
Brand
Infusion Set
Company
BIOENGINEERING LABORATORIES SRL
Model
MMT1173
Device description
Pump Tubing 4x6mm
Published
2024-12-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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
E261MMT11731PackageHIBCC25Not in Commercial Distribution
E261MMT11732PackageHIBCC2Not in Commercial Distribution
E261MMT11730PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Urological irrigation setA collection of sterile items intended to be used for the infusion of fluids used to flush the urethra and bladder. It typically includes tubing, connectors, a syringe, a roller clamp and other items used for flushing or continuous irrigation in procedures such as a cystoscopy or transurethral resection (TUR). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius

Regulatory Flags#

DUNS number
447644969
Device count
1
Premarket exempt
true
Lot or batch
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
E261UDA462150AtmosUD-A462152024-10-10
E261UDA582450AtmosUD-A582452024-09-03
E261UDAELN0AtmosUD-AELN2024-09-03
E261UDA362050AtmosUD-A362052024-09-02
E261MMT11731Infusion SetMMT11732024-12-09
E261UDA462151AtmosUD-A462152024-10-10
E261UDA582451AtmosUD-A582452024-09-03
E261UDAELN1AtmosUD-AELN2024-09-03
E261UDA362051AtmosUD-A362052024-09-02

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
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
18717775955556Flowstar NSMedical Measurement Systems B.V.EXQ2024-05-24